[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-limb-threatening-ischemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-limb-threatening-ischemia":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,52,76,103,130,155,182,202,229,257,283,303,332,359,380,405,434,455,477,496,521,544,568,594,617],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100613743","orbital-atherectomy-for-lesion-preparation-in-patients-with-chronic-limb-threatening-ischemia-100613743",false,"NCT07270562","ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia","ORACLE","Inclusion Criteria:\n\n1. Rutherford classification category ≥4;\n2. Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;\n3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography;\n4. Patients competent and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);\n2. Inadequate inflow (\\>30% stenosis) following optimization;\n3. Insufficient direct outflow (less than 1 run-off vessel);\n4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;\n5. Patients planned to receive an above ankle amputation of the target limb;\n6. Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.",[25,26],"Chronic Limb Threatening Ischemia","Chronic Limb-Threatening Ischemia",[28,29,30,31,32,33,34,35,36,37,38,39],"CLTI","Peripheral artery disease","Orbital atherectomy","Observational cohort study","Chronic limb ischemia","Critical limb-threatening ischemia","Calcified peripheral artery lesions","Vessel preparation","Femoropopliteal arteries","Infrapopliteal arteries","OA","Atherectomy for calcified lesions","NOT_YET_RECRUITING","2026-07-01",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":21},"2026-08",{"date":48,"type":21},"2031-12",{"name":50,"class":51},"Cardiovascular and Interventional Radiological Society of Europe","OTHER",{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100613744","resorbable-scaffolds-with-everolimus-elution-for-the-treatment-of-infrapopliteal-artery-disease-in-patients-with-chronic-limb-threatening-ischemia-100613744","NCT07270575","REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia","RESCUE","Inclusion Criteria:\n\n1. Rutherford classification category ≥4;\n2. Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation;\n3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography;\n4. Patients competent and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);\n2. Inadequate inflow (\\>30% stenosis) following optimization;\n3. Insufficient direct outflow (less than 1 run-off vessel);\n4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;\n5. Patients planned to receive an above ankle amputation of the target limb;\n6. Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).",{"count":60,"type":21},400,"RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings. The study focuses on people who have heavily calcified arteries in the infrapopliteal areas of the leg.\n\nThese drug-eluting resorbable scaffolds release a medication that helps prevent the inner wall of the blood vessel from thickening after injury or surgery. This can reduce the chance of the artery becoming blocked again (a problem called restenosis), while also giving temporary structural support to the vessel. Over time, the scaffold naturally dissolves in the body, which may lower the long-term risks associated with permanent metal stents.",[25,26],[28,64,65,29,66,67,68,69,70,34,37],"Critical Limb-Threatening Ischemia","Infrapopliteal artery disease","Esprit BTK Everolimus Eluting Resorbable Scaffold","Drug-eluting resorbable scaffold","Resorbable vascular scaffold","Real-world evidence study","Patients with infrapopliteal disease",{"date":43,"type":44},{"date":46,"type":21},{"date":74,"type":21},"2032-12",{"name":50,"class":51},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100628744","vessel-recoil-in-specific-clti-populations-100628744","NCT07465627","Vessel Recoil in Specific CLTI Populations","Early Vessel Recoil Following Below-the-knee (BTK) Artery Treatment With the Spur Peripheral Retrievable Scaffold System in Specific Patient Populations With Chronic Limb-threatening Ischemia (CLTI) - The DEEPER CHALLENGE Single Center Prospective Study","General Inclusion Criteria:\n\n1. Subject is willing and able to provide informed consent\n2. Subject is able to comply with the study protocol and with follow-up\n3. Life expectancy \\>1 year in the investigator's opinion\n4. Subject is \\> 18 years of age\n5. Subject must have symptoms of limb ischemia, determined by clinical symptoms of RC 4 or 5, including rest pain (RC 4) and\u002For minor tissue loss (RC 5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation\n6. Subject has stenotic, restenotic or occlusive lesions located in BTK vessels in pre-screening with CTA, MRA or angiography prior to the index procedure.\n7. Subject suffers from diabetes and\u002For receives chronic hemodialysis for KD (for at least 6 months)\n\n   * Diabetes cohort: Subject requires for estimated glomerular filtration rate (eGFR) ≥ 25ml\u002Fmin (within 30 days of procedure)\n   * Hemodialysis cohort: Subject has been receiving hemodialysis treatment for ≥ 6 months. (Note: subjects with diabetes who also receive chronic hemodialysis will be excluded from the diabetes cohort and will be included only in the hemodialysis cohort).\n\nAngiographic Inclusion Criteria:\n\n1. Target lesion can be successfully crossed with a guidewire.\n2. Target lesion must be located in BTK arteries. Treatment of the distal popliteal segment (P3) is permitted provided that sizing remains appropriate (no more than 4.5 mm in diameter).\n3. Target vessel reconstitutes at or above the medial ankle, with the target treated segment extending no more than 10 mm beyond the ankle.\n\n   1. If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.\n   2. If the peroneal artery is treated, there must be at least one collateral supplying the foot.\n4. Target vessel reference diameter is measured to be between 2.5 mm to 4.5 mm in diameter.\n5. Only one artery may be treated with the Spur device.\n\n   a. Non-target infrapopliteal lesions requiring treatment must be treated prior to treatment of the target lesion. Treatment of the target vessel\u002Flesion with the Spur device may be performed only if treatment of the non-target vessel(s)\u002Flesion(s) does not result in a complication which may compromise the outflow of the target lesion or result in a major adverse limb event.\n6. The treated segment is defined as the total length of artery treated with the Spur device. Total target treatment length must be \\\u003C 250mm with a maximum segment of 220 mm separated by 30 mm of healthy tissue between treated lesions.\n7. Successful pre-dilatation of the target lesion as outlined in the procedure instructions, defined as resulting in stenosis ≤ 50%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to the insertion of the Spur device.\n8. Iliac, SFA and popliteal inflow lesions can be treated during the index procedure. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. Inflow lesions must have a healthy vessel segment of \\>30 mm between the study lesion and the treated segment, defined as ≤ 50% stenosis.\n9. The Spur must be deployed from antegrade access.\n\nGeneral Exclusion Criteria:\n\n1. Subject is unwilling or unlikely to comply with the duration of the study (up to 12 months +\u002F-30 days post intervention) in the opinion of the investigator\n2. Subject is pregnant or planning to become pregnant during the course of the trial\n3. Subject is breastfeeding or planning to breastfeed during the course of the trial\n4. Subject has an active and uncontrolled systemic infection, including septicemia or bacteremia\n5. Subject has documented active osteomyelitis proximal to the phalanges of the target limb. Osteomyelitis in the digit(s) of the target foot is permitted.\n6. Subject has a wound above the ankle and\u002For a heel wound\n7. Subject has planned or had previous major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted.\n8. Subject with poor and insufficient general condition and\u002For comorbidities not allowing for endovascular treatment as per the investigator's discretion\n9. Diabetes cohort: subject has impaired renal function as defined by an eGFR \\\u003C 25 mL\u002Fmin within 30 days of procedure\n10. Hemodialysis cohort: subject has been receiving hemodialysis treatment for less than 6 months\n11. Subject with inability to comply with antiplatelet and\u002For anticoagulation therapy as per the facility's standard of care\n12. Subject with known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which do not allow for an adequate peri- and post-procedural treatment\n13. Subject with known allergies or sensitivities to Paclitaxel or Sirolimus balloon coatings\n14. Subject with known allergies or sensitivities to contrast media that cannot be adequately pre-treated prior to the index procedure\n15. Subject with known allergies or sensitivities to nitinol or nickel\n16. Subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.\n17. Subject with prior stent(s) within the target vessel, or bypass surgery of or within the target vessel\n18. Subject had previous treatment of the target vessel \\\u003C30 days prior to index procedure\n\nAngiographic exclusion criteria:\n\n1. Angiographic evidence of thrombus within target limb\n2. Inability to obtain antegrade access in the limb from which the Spur can be deployed\n3. Any lesion characteristics, that in the investigator's opinion, would not be amenable to endovascular standard techniques\n4. Significant \\> 50% stenosis of inflow arteries or unsuccessful treatment of inflow lesions\n5. \\> 50% stenosis, flow-limiting dissection (Type D or greater), aneurysm or thrombus of the target lesion following pre-dilation\n6. Inability to obtain additional imaging 15 minutes after target lesion treatment for recoil evaluation.",{"count":84,"type":21},40,"Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene. High-risk PAD populations including patients with end-stage renal disease and or diabetes also experience worse outcomes with significantly increased rates of amputation and mortality.\n\nAlthough some patients with PAD are best treated with a combination of medical management, exercise and lifestyle modification, revascularization is indicated in those with advanced stages of disease and particularly in the presence of CLTI. Revascularization of below-the-knee (BTK) arteries is required for most patients suffering from CLTI, but treatment faces numerous challenges comprising calcification, small vessel size, long-lesion length and early elastic recoil. With regard to these challenges, numerous innovative techniques and devices have been developed within the past decades to optimize endovascular treatment of BTK vessels.\n\nThe Spur Peripheral Retrievable Scaffold System (Spur) was developed to directly address many of these pitfalls of infrapopliteal arterial disease. The premise of the design of the Spur is to provide temporary mechanical scaffolding and to prepare the vessel for treatment with a drug-coated balloon (DCB) to enhance drug absorption by creating channels in the endothelium by the deployed Spur.\n\nThe objective of this study is to perform a prospective, single-center, single-arm, non-randomized study to evaluate acute vessel recoil following BTK treatment with the Spur Retrievable Scaffold System in combination with a commercially available DCB in specific patients populations. Specific patient populations that are selected to participate in this study are either at high risk to discover unfavorable outcomes with standard techniques due to a high complexity of lesions and\u002For patients that are not adequately mirrored in available studies. The patient cohorts that will be studied are diabetics and patients on hemodialysis (for at least 6 months). As women are commonly under-represented in comparable trials, this study requires at least 50% of women for each cohort.\n\nThe primary endpoint is vessel recoil within 15 minutes post treatment assessed with angiography. Secondary endpoints will be followed out to 12 months.",[25],[88,89,90,91,92],"vessel recoil","peripheral arterial disease","endovascular revascularization","below-the-knee","chronic limb-threatening ischemia","RECRUITING","2026-06-29",{"date":41,"type":44},{"date":97,"type":21},"2026-07",{"date":99,"type":21},"2028-09",{"name":101,"class":51},"Medical University of Graz",1,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":102},"100644498","predictors-of-major-adverse-limb-events-after-endovascular-iliac-stenting-a-real-world-cohort-study-100644498","NCT07672249","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study (PREMISE-ILIAC Study)","PREMISE-ILIAC","Inclusion Criteria:\n\nAdult patients aged ≥18 years, of both male and female sex\n\n* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and\u002For external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography\n* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy\n* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy\n* De novo iliac lesions only\n* Availability of complet\n\nExclusion Criteria:\n\nPrimary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).\n\n* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).\n* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).\n* Hybrid procedures with concomitant infrainguinal bypass surgery.\n* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.\n* Loss to follow-up without documented clinical outcomes.",{"count":112,"type":21},98,"Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.\n\nDespite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.\n\nThis retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.",[115,116,26,117],"Peripheral Arterial Disease","Aortoiliac Occlusive Disease","Intermittent Claudication",[115,119,120],"Iliac Artery Stenting","Endovascular Revascularization","2026-06-26",{"date":123,"type":44},"2026-06-30",{"date":125,"type":44},"2026-06-16",{"date":127,"type":21},"2026-07-16",{"name":129,"class":51},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":154},"100541486","acoart-litos-pcb-below-the-knee-global-trial-100541486","NCT06330493","AcoArt Litos PCB Below-the-knee Global Trial","Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia","Inclusion Criteria:\n\n\\- General Inclusion Criteria\n\n1. Age ≥ 18 years at the time of consent;\n2. Subjects has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Institutional Review Board(IRB)\u002FEthics Commitee(EC) approved consent form;\n3. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses);\n4. Life expectancy \\> 1 year in the Investigator's opinion;\n5. Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5;\n6. In case of Rutherford category 5: Subjects with documented wound score 0-1, infection grade 0-2 and ischemia grade 2-3 according to the wound ischemia foot infection (WIfI) classification;\n7. No other prior surgical or vascular interventions within 2 weeks before and\u002For planned 30 days after the protocol treatment.\n\n   * Angiographic Inclusion Criteria\n8. Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated with available device size matrix;\n9. Total length of target lesion (including significant stenosis 70\\~99% or occlusion) ≤ 190mm;\n10. The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not extend proximal to the P3 segment of the popliteal artery indicated by the tibial plateau or below the tibiotalar joint(arteries of the foot). The treatment(investigational device or PTA, including pre-dilatation) may not extend beyond these indicated regions for more than 1cm;\n11. Presence of documented run-off to the foot(clearly visible at least one of the following run-off vessels; dorsalis pedis or pedal arch or plantar arteries by angiography). The target vessels should give direct or indirect run-off to the foot;\n12. Absence of flow-limiting(≥ 50% stenosis) in-flow lesions confirmed by angiography. Patients with flow-limiting inflow lesions can be included if the lesion(s) have been treated successfully before enrollment, with a maximum residual restenosis of ≤30% per visual assessment. If an inflow lesion must be treated within or proximal to the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy vascular segment between this(treated) lesion and the infrapopliteal target lesion;\n13. Successful pre-dilatation of the(entire) target lesion. Success being documented by angiographic visual estimate of ≤ 50% residual diameter stenosis of the target lesion and no flow limiting dissection(\\\u003C Grade D dissection). Target lesion is not considered non-dilatable by the operator due to concentric, circumferential calcium and target lesion can be treated successfully by balloon angioplasty without the need for bail-out stenting.\n\nExclusion Criteria:\n\n\\- General Exclusion Criteria\n\n1. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre- or post-procedure. A planed amputation including and below the metatarsal level(1 or multiple rays) is accepted.\n2. Recent MI or stroke \\\u003C 30 days prior to the index procedure;\n3. Known or suspected active infection at the time of the index procedure(abnormal white blood cell count, fever, sepsis, or positive blood culture), with the exception of a localized, controlled infection of a lower extremity wound on the target limb(only WIfI infection grade 0-2 allowed);\n4. Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;\n5. Subjects not independently ambulating.\n6. Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation; Subjects with uncomplicated ulcers can be included;\n7. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement;\n8. Subjects with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica on active treatment;\n9. Subjects with impaired renal function defined as eGFR \\\u003C30 ml\u002Fmin or on dialysis;\n10. Patient receiving systemic corticosyeroid therapy(expected dosage exceeding 5 mg of prednisolone or equivalent, per day, during the initial 9 months after procedure);\n11. Known allergies or sensitivities to heparin, aspirin(ASA), other anticoagulant\u002Fanti-platelet therapies which could not be substitued, and\u002For paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure;\n12. Subjects currently enrolled in another investigational device, drug, or biological trial;\n13. Femal subjects who are breast feeding at the time of enrollment;\n14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;\n15. Any severe medical comorbidities(e.g., untreated CAD\u002FCHF, NYHA class IV heart failure, Left Ventricular ejection fraction(LVEF) \\\u003C\u002F= 30%(obtained within 1 month of index procedure), severe COPD, metastatic malignacy, etc.) that would preclude compliance with the study protocol or currently receiving immune-suppressive, chemotherapeutic, or radiation therapy;\n\n    * Angiographic Exclusion Criteria\n16. Occlusions located or extending distal to the ankle joint space;\n17. Untreated (≥50% measured by angiography) inflow lesion or occlusion in the ipsilateral iliac, SFA nad popliteal arteries;\n18. Failure to obtain a ≤30% residual stenosis in pre-existing, hemodynamically significant(≥50% measured by angiography) in flow lesions in the ipsilateral iliac, SFA and popliteal artery. Inflow lesions should be treated per standard of care;\n19. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization);\n20. Previous procedure with drug-coated balloons in the target vessels within 6 months prior to index procedure.\n21. Aneurysm in the target vessel;\n22. Angiographic evidence of thrombus within target limb;\n23. Pre-dilatation resulted in a major(≥ Grade D) flow-limiting dissection(observed on 2 orthogonal views) or residual stenosis \\>50%;\n24. Use of alternative therapy, e.g. atherectomy, scoring balloon, laser, radiation therapy, stents as part of target vessel treatment.",{"count":138,"type":21},288,"INTERVENTIONAL",[141],"NA","The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)",[26],"2026-06-22",{"date":146,"type":44},"2026-06-24",{"date":148,"type":44},"2025-10-10",{"date":150,"type":21},"2032-10",{"name":152,"class":153},"Acotec Scientific Co., Ltd","INDUSTRY",19,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":139,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100591350","intravascular-ultrasound-for-peripheral-artery-disease-revascularization-100591350","NCT06979284","Intravascular Ultrasound for Peripheral Artery Disease Revascularization","Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial","CLARITY","Inclusion Criteria:\n\n1. Patients presenting with lower extremity PAD manifesting as CLTI:\n\n   a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6, with the following supporting hemodynamic criteria1: i. For ischemic rest pain (Rutherford category 4): Ankle systolic pressure \\\u003C 40mmHg, toe pressure \\\u003C 30mmHg, or flat-line transtarsal pulse volume recording, OR ii. For tissue loss (Rutherford category 5, 6): Ankle systolic pressure \\\u003C 60 mmHg, toe pressure of \\\u003C 40mmHg, or flat-line transtarsal volume recording, AND\n2. Scheduled to undergo percutaneous revascularization, AND\n3. Informed consent\n4. Imaging evidence of an obstructive or occluded lesion (\\> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging.\n5. An infrapopliteal lesion must be located in the proximal 2\u002F3 of native infrapopliteal vessels, with a vessel diameter of \\> 2.5mm by investigator visual assessment.\n6. The distal margin of the most distal target lesion must be located \\> 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (\\>50% stenosis).\n\nExclusion Criteria:\n\n1. The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.\n2. The presence of any medical conditions precluding percutaneous revascularization\n3. The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.\n4. The subject is bedridden or unable to walk (with assistance is acceptable).\n5. Life expectancy \\\u003C 12 months\n6. Age \\\u003C 18 years\n7. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia\n8. Planned above-ankle amputation of the index limb within four weeks of the index procedure.\n9. Obstructive supra-inguinal \"inflow\" (\\>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure.\n10. The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity \\\u003C 1 year before the index procedure and is not independently walking.\n11. Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.\n\n    1. Osteomyelitis that extends proximal to the metatarsal heads\n    2. Gangrene involving the plantar skin of the forefoot, midfoot or heel\n    3. Deep ulcer or large shallow ulcer (\\> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel\n    4. Full-thickness heel ulcer\n    5. Any wound with calcaneal bone involvement\n    6. Wounds that would require flap coverage or complex wound management for large soft tissue defect\n    7. Full-thickness wounds on the dorsum of the foot with exposed tendon or bone.",{"count":164,"type":21},772,[141],"The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.",[168,25,169,170,171],"Peripheral Arterial Disease(PAD)","Intravascular Ultrasound","Major Adverse Limb Events","Restenosis","2026-06-04",{"date":174,"type":44},"2026-06-08",{"date":176,"type":44},"2025-12-05",{"date":178,"type":21},"2030-10",{"name":180,"class":51},"Hamilton Health Sciences Corporation",2,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100527583","chronic-limb-threatening-ischemia-treated-with-intravascular-lithotripsy-observational-study-100527583","NCT06149650","Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study","CALCIO","Inclusion Criteria:\n\n* Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)\n* Femoropopliteal and\u002For crural calcified lesions visible on fluoroscopy;\n* Treatment with IVl using the Shockwave Medical IVL System.\n\nExclusion Criteria:\n\n* \\\u003C 18 years old;\n* Incapacity or refusal to give informed consent;\n* Ongoing pregnancy;\n* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.",{"count":60,"type":21},"CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.",[26],[28],"2026-05-11",{"date":195,"type":44},"2026-05-13",{"date":197,"type":44},"2024-07-15",{"date":199,"type":21},"2028-12-31",{"name":50,"class":51},39,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":139,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100463320","promise-iii-percutaneous-deep-vein-arterialization-for-the-treatment-of-late-stage-chronic-limb-threatening-ischemia-100463320","NCT05313165","PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia","Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial","Inclusion Criteria:\n\n1. Subject must be ≥ 18 and ≤ 95 years of age\n2. Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP \u002F TcPO2 \\\u003C 30 mm Hg) and\n\n   1. Rutherford Classification 5, ischemic ulceration or\n   2. Rutherford Classification 6, ischemic gangrene\n3. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.\n4. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.\n5. Subject is willing and able to sign the informed consent form.\n6. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.\n7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.\n8. Primary wound is stable (e.g., not rapidly deteriorating and\u002For showing signs of healing).\n9. Stable glycemic control, HbA1C \\\u003C 10% (\\\u003C269mg\u002FdL)\n10. Subjects requiring dialysis may be included, provided they meet all the following requirements:\n\n    * On dialysis for \\> 6 months\n    * Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis\n    * Serum albumin \\> 30 g\u002Fliter\n    * BMI \\> 20\n\nExclusion Criteria:\n\n1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.\n2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.\n3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.\n4. Absence of adequate viable tissue in target foot.\n5. Life expectancy less than 12 months.\n6. Documented myocardial infarction or stroke within previous 90 days.\n7. Active infection (e.g., fever, significantly elevated WBC count \\>20.0 x 109\u002FL, and\u002For positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).\n8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.\n9. Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).\n10. Lower extremity vascular disease that may inhibit the procedure and\u002For jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).\n11. Significant acute or chronic kidney disease with a serum creatinine of \\> 2.5 mg\u002Fdl in subjects not undergoing dialysis.\n12. Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.\n13. Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.\n14. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.\n15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.","95 Years",{"count":211,"type":21},100,[141],"A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.",[215,26,115],"Critical Limb Ischemia",[28,217,218],"PAD","CLI","2026-04-13",{"date":221,"type":44},"2026-04-16",{"date":223,"type":44},"2022-12-22",{"date":225,"type":21},"2027-05-01",{"name":227,"class":153},"LimFlow, Inc.",30,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":139,"phases":239,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100634183","phase-3-colchicine-in-chronic-limb-threatening-ischemia-100634183","NCT07536373","Colchicine in Chronic Limb-Threatening Ischemia","Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia","CIRCLE-Asia","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Documented chronic limb-threatening ischemia, meeting the following:\n\n   * Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND\n   * Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND\n   * Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients without prior revascularization; ABI ≤0.85 or TBI ≤0.65 for those with prior revascularization OR\n   * Ischemic rest pain alone (Rutherford class 4) defined as ankle systolic pressure \\\u003C50 mmHg, toe pressure of \\\u003C30 mmHg, transcutaneous PO2 of \\\u003C30 mmHg, or flat-line transtarsal pulse volume recording OR\n   * Tissue loss with or without ischemic rest pain (Rutherford class 5) defined as ankle systolic pressure \\\u003C70 mmHg, toe pressure of \\\u003C50 mmHg, transcutaneous PO2 of \\\u003C30 mmHg, or flatline transtarsal pulse volume recording\n3. Recent successful revascularization:\n\n   * Underwent technically successful endovascular therapy (EVT) or surgical bypass within the last 7 days prior to randomization\n   * For individuals requiring multiple revascularization attempts on the same index leg, the procedure considered for eligibility (in other words, the qualifying or index procedure) must be the final planned or anticipated revascularization attempt\n   * There must be demonstrated graft or vascular patency after the qualifying revascularization procedure with one in-line blood flow to the foot, either by angiography, duplex ultrasound, CTA or MRA\n   * There must be no immediate plan for reintervention\n4. Informed Consent:\n\n   * Demonstrated ability and willingness to adhere to the study protocol, attend scheduled follow-up visits, complete all required assessments, and provide written informed consent\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3\n3. Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening\n4. Failure to establish at least one tibial artery outflow after revascularization\n5. Recent acute limb ischemia events within 2 weeks of screening\n6. Clinical signs of active, uncontrolled, severe limb infection or septicemia, such as fever exceeding 38.5°C, a white blood cell count above 15,000 cells\u002FµL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization)\n7. Unstable hemodynamics after the index revascularization procedure\n8. Unable to tolerate any antiplatelet agent or with severe bleeding diathesis\n9. Acute coronary syndrome, acute stroke, or hospitalization for heart failure within 30 days of screening\n10. Any contraindication or known intolerance to colchicine\n11. Requirement for colchicine for another indication\n12. Need for use of medications known to have drug-drug interactions with colchicine, particularly drugs known to inhibit CYP3A4 or P-glycoprotein\n13. Active hepatitis or severe liver cirrhosis (Child Pugh C)\n14. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception\n15. Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s)\n16. Life expectancy \\\u003C1 year",{"count":238,"type":21},200,[240],"PHASE3","Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes.\n\nColchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI.\n\nThe CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure.\n\nThis is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assigned in a 1:1 ratio to receive either colchicine 0.5 mg once daily or a matching placebo pill, in addition to their usual medications, for 12 months. Neither the patients nor the study doctors will know which treatment each patient receives.\n\nThe main outcome of interest is amputation-free survival, defined as the time until major amputation of the affected leg (above the ankle) or death from any cause, over 12 months of follow-up. The study will also assess other important outcomes including major limb complications, heart attacks, strokes, wound healing, changes in blood flow measurements, inflammatory blood markers, quality of life, and medication safety.\n\nThis pilot trial will provide the first randomized evidence on the potential benefits and safety of colchicine in CLTI patients and will help inform the design of a larger definitive trial.",[26],[235,244,29,245,246],"Chronic limb-threatening ischemia","Colchicine","Amputation-free survival","2026-04-11",{"date":249,"type":44},"2026-04-17",{"date":251,"type":21},"2026-04-15",{"date":253,"type":21},"2030-04",{"name":255,"class":51},"Shin Kong Wu Ho-Su Memorial Hospital",5,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":139,"phases":268,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100620067","phase-2-safety-of-antithrombotic-heparin-proteoglycan-mimetic-apac-in-peripheral-arterial-occlusive-disease-and-chronic-limb-threatening-ischemia-100620067","NCT07352800","Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia","A Phase 2a Open-label Study to Assess the Safety, Tolerability, and Dosing Regimen of Antithrombotic Heparin Proteoglycan Mimetic APAC in Patients With Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia Undergoing Endovascular Revascularization","HEALING","Inclusion Criteria (Parts A1, B1 and B2):\n\n1. Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.\n2. Diagnosed with a. PAOD classification Fontaine stage III or IV , b. the total length of the treatment-targeted arterial segment ≥ 5 cm below the knee lesion(s) based on contrast-enhanced computed tomography angiography (CTA)\u002Fmagnetic resonance angiography (MRA)\u002Fdigital subtraction angiography (DSA) (Part B1 and B2), c. superficial forefoot wounds without overt infection and bone invasion (WIfI 0-1 and 2 limited to digits and WIfI infection 0-1) allowed, d. undergoing endovascular intervention. (In Part A1, if prescheduled endovascular intervention would take place before the Day 8 study visit, patient is not to be enrolled.)\n3. CTA\u002FMRA\u002FDSA with contrast agent performed within 3 months prior to study enrolment as part of diagnostics of PAOD, with results available in the patient's medical records.\n4. Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg once a day \\[QD\\]) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC administration.\n5. Adequate lipid lowering therapy, as evaluated by the investigator.\n6. Capability and willingness to provide valid, voluntary written informed consent for the study.\n7. Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile \\[hysterectomy, bilateral salpingectomy and bilateral oophorectomy\\]) must be willing to use highly effective contraception while on study treatment. Highly effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; and sexual abstinence.\n8. Males must refrain from sperm donation while on study treatment.\n\nInclusion Criteria (Part A2):\n\n1. Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.\n2. Diagnosed with a. PAOD classification Fontaine stage IIa and IIb, b. not prescheduled for endovascular revascularization within 90 days of first APAC administration.\n3. Moderate to severe arterial disease, ABI \\\u003C 0.7.\n4. Patients should be capable of performing evaluable treadmill exercise test.\n5. Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC administration.\n6. Adequate lipid lowering therapy, as evaluated by the investigator.\n7. Capability and willingness to provide valid, voluntary written informed consent for the study.\n8. Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile \\[hysterectomy, bilateral salpingectomy and bilateral oophorectomy\\]) must be willing to use highly effective contraception while on study treatment. Highly effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); IUD; IUS; bilateral tubal occlusion; vasectomized partner; and sexual abstinence.\n9. Males must refrain from sperm donation while on study treatment.\n\nExclusion Criteria:\n\n1. Any ischemic lesions of the heel and midfoot and lesions (wounds or gangrene) invading bones, joints, or tendons at metatarsophalangeal joints or more proximal sites.\n2. Acute limb-threatening ischemia (e.g., thromboembolic disease).\n3. Medical history of, or an existing aneurysm.\n4. Endovascular revascularization intervention is done from the contralateral side using cross-over access (Part B1 and B2).\n5. Medical history of, or condition known to be associated with impaired hemostasis, i.e., increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic stroke, thrombotic or thromboembolic stroke, gastrointestinal bleeding within 6 months of enrolment, or retroperitoneal bleeding any time, or any inherited or acquired bleeding disorder, i.e., von Willebrand disease or hemophilia or other relevant diagnosis causing impaired hemostasis.\n6. Current use of therapeutic dose of anticoagulation (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason. (Use of dual pathway inhibition \\[= acetylsalicylic acid 100 mg + rivaroxabahn 2.5 mg x 2\\] is not a contraindication, but will be temporarily halted for the day of intervention and day of repeating dosing)\n7. Patients treated with combined antiplatelet agents: aspirin + P2Y12 antagonist (clopidogrel, ticagrelor, prasugrel).\n8. Diagnosis of autoimmune diabetes mellitus (Type 1 diabetes, or latent autoimmune diabetes in adults \\[LADA\\]) vasculitis, rheumatoid arthritis, inflammatory bowel diseases, or other general autoimmune diseases.\n9. Body mass index \\> 35 kg\u002Fm\\^2.\n10. Patients with clinically significant acute infection, as judged by the investigator.\n11. Use of non-steroidal anti-inflammatory medications within 2 weeks prior to the first dose of APAC or during the treatment period. If medication for pain is required, paracetamol or tramadol (e.g. an opioid patch) may be used.\n12. Use of selective serotonin reuptake inhibitor (SSRI) medication within 2 weeks prior to the first dose of APAC or during the treatment period.\n13. Peroral use of glycosaminoglycans or omega 3 or related products within 28 days before IMP treatment.\n14. Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy prior to the screening visit or scheduled for such an intervention during the study.\n15. Uncontrolled arterial hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n16. Blood hemoglobin concentration \\\u003C120 g\u002FL or \\> 170 g\u002FL (men) and \\\u003C110 g\u002FL or \\>160 g\u002FL (women) at screening.\n17. Blood platelet count \\\u003C150 x 10\\^9\u002FL or \\> 450 x10\\^9\u002FL and\u002For leukocyte count in the lower reference range or not above \\>12 x 10\\^9\u002FL.\n18. Clinically significantly prolonged plasma PT (\\> 1.2-fold) or a value of less than 50% (when normal reference range is 70-130%).\n19. APTT above the upper limit of the reference range.\n20. Patients with a medical history of heparin-induced thrombocytopenia.\n21. Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) level \\> 2.5 x the upper limit of normal (ULN) at screening.\n22. A diagnosis of severe chronic kidney disease, defined as having an eGFR category 4 or 5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) or albuminuria stage A3 (uACR \\>300 mg\u002Fg).\n23. Patients with an active malignancy, or who have received treatment for any malignancy including bone marrow transplantation within 5 years before the screening visit, except for localized basal cell or squamous cell skin cancer that has been cured at least 90 days before screening.\n24. Previous treatment with APAC.\n25. Patients with known allergy or hypersensitivity to heparin, or heparin products, APAC, and\u002For antiplatelet agents (e.g., aspirin or clopidogrel), and protamine sulphate, the reversal agent for APAC.\n26. Participation in an investigational drug or device study within 90 days prior to screening.\n27. Patients who have ever received treatment with a gene therapy.\n28. Patients with known antiphospholipid antibody syndrome or other known significant thrombophilia (homozygosity for FV Leiden or FIIG20210A mutation, or phospholipid antibody syndrome, deficiency of antithrombin, protein C or protein S or combined thrombophilia).\n29. Any concomitant disease or condition or treatment that could interfere with, or the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study as judged by the investigator.\n30. Patients with severe comorbidities and limited life expectancy as judged by the investigator.\n31. Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n32. Patients with current and\u002For history of drug abuse (defined as illicit drug use) or alcohol abuse (defined as daily consumption of more than 23-24 and 12-16 alcoholic drinks per week in males and females, respectively).","85 Years",{"count":267,"type":21},42,[269],"PHASE2","The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant \\[APAC\\]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed arteries in their legs (peripheral arterial occlusive disease \\[PAOD\\]), and in patients with severely restricted poor blood flow to the legs that threatens limb health (chronic limb-threatening ischemia \\[CTLI\\]). The study also aims to find the best dose of the medicine. The study consists of two parts: Part A will include patients with PAOD and CTLI, Part B will only include patients with CTLI who are having a procedure to restore blood flow in their legs. Both parts will be subdivided into two subgroups (A1 and A2, B1 and B2) which will test different APAC doses and compare single dosing to weekly dosing for 4 weeks. APAC is injected into the blood. The possible treatment response will be compared either to a placebo (a look-alike substance that contains no drug), or to the current standard treatment. Patients will participate in the study for up to 90 or 180 days. During this time, patients will be regularly examined and asked to answer questions concerning their quality of life.",[272,26],"Peripheral Arterial Occlusive Disease","2026-04-08",{"date":275,"type":44},"2026-04-09",{"date":277,"type":44},"2026-01-29",{"date":279,"type":21},"2027-06-30",{"name":281,"class":153},"Aplagon Oy",3,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":139,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":102},"100630512","woundsome-revascularization-in-chronic-limb-threatening-ischemia-100630512","NCT07488637","Woundsome Revascularization in Chronic Limb-Threatening Ischemia","Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With Chronic Limb-Threatening Ischemia","Inclusion criteria:\n\n1\\. Patients with chronic limb-threatening ischemia (CLTI) with tissue loss (Rutherford Class 5 or 6, or WIFI stage 2-4) 2. Patients with infrapopliteal arterial occlusions requiring revascularization\n\n\\-\n\nExclusion Criteria:\n\n1. Patients with unsalvageable limbs\n2. Patients with acute limb ischemia (ALI)\n3. Patients with non-atherosclerotic diseases such as vasculitis, including:\n\n   Large vessel vasculitis (e.g., giant cell arteritis, Takayasu arteritis) Medium vessel vasculitis (e.g., polyarteritis nodosa, Kawasaki disease) Small vessel vasculitis (e.g., granulomatosis with polyangiitis, microscopic polyangiitis) Other types (e.g., Behçet's disease, Buerger's disease)\n4. Patients with contraindications to contrast medium\n5. Patients with aortoiliac or femoropopliteal occlusive disease",{"count":291,"type":21},50,[141],"Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging \"woundsome\" concept focuses instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and",[26],"2026-03-27",{"date":297,"type":44},"2026-04-01",{"date":297,"type":21},{"date":300,"type":21},"2027-10-01",{"name":302,"class":51},"Assiut University",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":313,"studyType":22,"phases":4,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100486901","durg-coated-balloon-angioplasty-in-infrapopliteal-lesions-100486901","NCT05620095","Durg Coated Balloon Angioplasty in Infrapopliteal Lesions","Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)","Act","Inclusion Criteria:\n\n1. Rutherford grade 4-6.\n2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.\n3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \\>20 mm. Lesions should not extend beyond the ankle joint.\n4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.\n5. At least one of the infrapopliteal arteries received a drug-coated balloon.\n6. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%.\n7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention.\n8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.\n9. Life expectancy\\> 24 months.\n\nExclusion Criteria:\n\n1. Blood flow was not successfully reestablished.\n2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.\n3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.\n4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.\n5. Pregnant and lactating women.\n6. Patients with Berg's disease.\n7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia",{"count":312,"type":21},1000,"1 Year","This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).",[316,317,25],"Arteriosclerosis","Peripheral Artery Disease",[319,320,321],"Drug-coated Balloon","Angioplasty","Below the knee","2026-03-20",{"date":324,"type":44},"2026-03-25",{"date":326,"type":44},"2020-12-01",{"date":328,"type":21},"2026-11-01",{"name":330,"class":51},"Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology",10,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":102},"100629236","symptomatic-and-systemic-atherosclerotic-plaque-activity-in-patients-with-peripheral-arterial-disease-using-novel-imaging-100629236","NCT07472049","Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging","SISYPHUS","Inclusion Criteria:\n\n* Male or female aged \\> 18 years\n* Symptomatic atherosclerotic peripheral artery disease;\n\n  * Intermittent claudication; with ankle\u002Farm blood pressure ratio \\\u003C0.90 or artery stenosis \\>50% in addition to at least one of the following;\n\n    * \\>1 vascular bed affected by atherosclerosis\n    * Diabetes\n    * Heart failure\n    * Chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2)\n  * Rest pain or necrosis of limb or gangrene of limb\n  * Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty\u002Fstent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery\n  * Leg or foot amputation for arterial vascular indications\n* Ability to give written or verbal informed consent\n\nExclusion Criteria:\n\n* Contraindication to colchicine or iodinated contrast\n* Long term requirement for colchicine for another clinical indication\n* Active diarrhoea\n* Recent lower limb revascularisation for symptomatic disease (\\\u003C6 weeks)\n* Renal failure (glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Cirrhosis or severe chronic liver disease\n* Women who are pregnant or breast-feeding\n* Women of child-bearing potential not protected by reliable contraception or is planning conception during the study\n* Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (apart from azithromycin)\n* Patients deemed unlikely to return for follow up\n* Life expectancy \\\u003C1 year\n* Inability or unwilling to give informed consent",{"count":211,"type":21},"The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.",[115,25],[343,344,345,346,347,348,349],"Peripheral arterial disease","Chronic limb threatening ischaemia","PET-CT","cardiovascular diseases","Sodium Fluoride","GP1","DOTATATE","2026-03-11",{"date":352,"type":44},"2026-03-16",{"date":354,"type":44},"2025-07-31",{"date":356,"type":21},"2029-07",{"name":358,"class":51},"University of Edinburgh",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":139,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":282},"100521579","bioresorbable-sirolimus-eluting-scaffold-treatment-for-below-the-knee-disease-100521579","NCT06071429","Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease","ELITE-BTK","General Inclusion Criteria\n\n1. Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board \u002F Ethics Committee.\n2. Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure.\n\n   Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.\n3. Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.\n4. Subject is ≥ 18 years of age.\n5. Subject agrees to complete all protocol-required follow-up visits, including angiograms.\n\n   Angiographic Inclusion Criteria\n6. Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery.\n7. Target lesion(s) must be located in the proximal 2\u002F3 of the native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.\n\n   Note: Up to two (2) target lesions and two different arteries can be treated\n8. All target lesions must be successfully crossed with a guidewire prior to randomization.\n\n   Note: For CTO, retrograde crossing of the lesion is allowed but treatment must be via antegrade.\n\n   Note: The most distal lesion must be treated before treating more proximal lesions.\n9. Distal tibial and pedal runoff for each target lesion must be patent (free of lesions with \\\u003C 50% stenosis). If the index vessel is either anterior or posterior tibial artery, outflow must be contiguous with a patent dorsalis pedis or common plantar artery.\n10. Inflow above-the-knee lesions must be treated successfully (\\\u003C 30% diameter stenosis by angiography without evidence of distal embolization, thrombus formation, or vessel rupture).\n\n    Note: Inflow lesions may be treated during the index procedure prior to target lesion(s) using the standard of care (including drug-eluting devices), without wiring the target lesion, if possible. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful.\n\n    Note: Atherectomy of non-target lesions is not allowed.\n11. Target lesion must have reference vessel diameter is between 2.75 - 3.75 mm by angiography. Vessel size measured by IVUS is highly recommended to verify RVD.\n12. Target lesion(s) is de novo or restenosed ≥ 70% stenosed by angiography. Note: In-stent restenosis is an exclusion criterion.\n13. The total target lesion length among all target lesions must not exceed 11 cm.\n14. Minimum target lesion length must be \\>14 mm.\n15. Total scaffold length must not exceed 12 cm, and include at least 2 mm of normal vessel from each pre-dilatation border.\n16. The target vessel must not have any other angiographic significant non-target lesions (≥ 50%).\n17. Tandem non-contiguous target lesions are allowed if there is a plaque-free zone of ≥ 2 cm between the lesions. Total lesion lengths must not exceed 11 cm.\n18. Target lesion(s) stenting does not block access to patent main named branches (tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery).\n19. Non-target below-the-knee lesions in non-target vessels must be successfully treated per standard of care prior to randomization without evidence of thrombosis, distal embolization, or vessel rupture.\n\n    Note: Drug-eluting and atherectomy devices for treatment of non-target lesions is not allowed.\n20. Subject has suitable common femoral (contralateral or antegrade ipsilateral) vascular access.\n\n    Note: Retrograde pedal approach is allowed for crossing but not for treatment of target lesion(s).\n21. At least one fully patent below-the-ankle artery (i.e., dorsalis pedis; common with either, lateral, or medial plantar arteries) without hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) must be present in the target limb.\n\nGeneral Exclusion Criteria\n\nSubjects must not meet any of the following general and angiographic exclusion criteria:\n\n1. Subject with Body Mass Index (BMI) \\\u003C 18.\n2. Subject is pregnant or nursing. Subjects who plan pregnancy during the clinical investigation follow-up period may not be enrolled.\n\n   Note: Subjects of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and agree to use contraception for 6 months.\n3. Estimated life expectancy \\\u003C1 year, in the opinion of the Investigator at the time of enrollment.\n4. Subject is permanently bedridden.\n5. Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including antiplatelet medications) or to contrast media and who cannot be adequately premedicated.\n6. Subject has planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.\n7. Subject has had revascularization procedure within the target vessel in the previous 3 months\n8. Subject has prior major amputation (above or below the knee or above the ankle) involving the target limb.\n\n   Note: Major amputation of the contralateral limb is allowed.\n9. Subject has planned surgical or endovascular procedure within 6 months following the index procedure.\n\n   Note: A planned minor amputation (toe and\u002For transmetatarsal amputation in either limb) is allowed. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful (\\\u003C 30% residual stenosis, no thrombi, distal emboli or vessel rupture).\n10. Subject who has severe ischemia (ABI ≥ 0.39).\n11. Subject who has neuropathic lesion(s) with no ischemic component (wounds or ulcers occur on pressure zones of the foot with or without Type 2 diabetes , deformed foot\u002Ftoes, hematoma, edema ).\n12. Subject has presence of osteomyelitis or any gangrene above the metatarsal-phalangeal joints, extensive tissue loss with exposed tendons or requiring complex or recurrent surgeries, full thickness heel ulcer, or pure neuropathic ulcers.\n13. Subject with uncontrolled diabetes with HbA1c \\> 10%.\n14. Subject has a prior stroke or myocardial infarction within 3 months of the index procedure.\n15. Subject has acute renal failure, severe or end-stage chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin), or requires dialysis.\n16. Subject has active systemic infection.\n17. Subject is receiving immunosuppression therapy and\u002For has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).\n18. Subject has active malignancy (receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the index procedure), active blood dyscrasia or coagulation disorder (platelet count \\\u003C 100,000 cells\u002Fmm3 or \\> 700,000 cells\u002Fmm3, a WBC \\\u003C 3,000 cells\u002Fmm3, or hemoglobin \\\u003C 8.0 g\u002Fdl).\n19. Subject is an incapacitated individual, defined as a person who is mentally ill, mentally handicapped, or an individual without legal authority to control their activities.\n20. Subject has significant comorbid condition(s), or other medical, social, or psychological conditions (such as history of substance abuse, e.g., alcohol, cocaine, heroin, etc.), that in the Investigator's opinion may limit the subject's ability to participate or comply with study instructions and follow-up. This includes subjects with symptomatic COVID-19 infection in the past 2 months or asymptomatic COVID-19 positive test in the past 1 month.\n\n    Angiographic Exclusion Criteria\n21. Angiographic evidence of thromboembolism or atheroembolism in the target or non-target vessel as confirmed by angiography.\n22. Non target lesion located in the popliteal P3 (infrageniculate) segment or treated with atherectomy.\n23. Presence of aneurysm or acute thrombus in the aorta or lower extremity arteries.\n24. Prior below-the-knee bypass in the target limb.\n25. Previously stented lesion(s) or the presence of stents in the target vessel.\n26. Target vessel(s) have distal hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) outside of the allowed treatment zone (presence of non-target lesions in the target vessel is an exclusion criterion).\n27. Lesions (target or non-target) with severe calcification (per PACSS 4 classification).\n28. Unsuccessful treatment of stenosis (≥ 50% stenosis) of in-flow arteries including the P3 segment of the popliteal artery (infrageniculate).\n29. Absence of a patent pedal artery. Absence of contiguous dorsalis pedis or common plantar arteries if the target vessels are anterior or posterior tibial arteries, respectively.\n30. Target lesion location requires bifurcation treatment with scaffolding of both branches (kissing scaffold is not allowed). In case of presence of disease at a bifurcation, one vessel can be treated as target and the other as non-target.\n31. Lesions (target or non-target) in which successful predilatation cannot be achieved.\n32. Planned atherectomy treatment of any target or non-target lesion.",{"count":367,"type":21},300,[141],"The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.",[26],"2026-02-05",{"date":373,"type":44},"2026-02-06",{"date":375,"type":44},"2025-04-11",{"date":377,"type":21},"2032-03-01",{"name":379,"class":153},"R3 Vascular Inc.",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":387,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":102},"100619091","expression-of-glp1-receptor-on-peripheral-blood-mononuclear-cells-in-advanced-peripheral-artery-disease-paving-the-way-for-glp1r-agonists-treatment-in-chronic-limb-threatening-ischemia-100619091","NCT07340112","Expression of GLP1 Receptor on Peripheral Blood Mononuclear Cells in Advanced Peripheral Artery Disease: Paving the Way for GLP1R Agonists Treatment in Chronic Limb Threatening Ischemia","EXCEL-CLTI","Inclusion Criteria:\n\n* Patients aged 40 years or older\n* Documented Peripheral Artery Disease (PAD): Patients must fall into one of the two following severity groups:\n\n  1. Intermittent Claudication (IC) Group: Defined by a maximum walking distance limited by intermittent claudication, associated with an Ankle-Brachial Index (ABI) \\\u003C 0.9 at rest.\n  2. Chronic Limb-Threatening Ischemia (CLTI) Group: Defined by ischemic rest pain and\u002For tissue loss (ulcers or gangrene) persisting for at least 15 days, associated with a toe pressure or a transcutaneous oxygen tension (tcPO2) \\\u003C 30 mmHg, according to the 2024 ESC guidelines.\n\nExclusion Criteria:\n\n* Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes\n* Current Specific Pharmacotherapy: Ongoing treatment with SGLT2 inhibitors (SGLT2i) or GLP-1 receptor agonists (GLP-1RA).\n* Infection: Presence of sepsis or an active systemic infection.\n* Malignancy: Active cancer or hematologic malignancies.\n* Immunosuppression: History of organ transplantation or autoimmune diseases currently requiring immunosuppressive therapy.\n* Known chronic inflammatory diseases.\n* Advanced Renal Failure: End-stage renal disease requiring dialysis.","40 Years",{"count":291,"type":21},"The goal of this observational study is to learn whether activation of the GLP-1 receptor could represent a therapeutic target by characterizing its expression and associated inflammatory mechanisms in patients with peripheral artery disease, according to disease severity, in adults with symptomatic lower-limb peripheral arterial disease.\n\nThe main questions it aims to answer are:\n\n* Is the level of GLP-1 receptor (GLP1R) expression on peripheral blood mononuclear cells (PBMC) different between patients with intermittent claudication (ischemia of effort) and those with chronic limb-threatening ischemia?\n* Is GLP1R expression associated with inflammatory and oxidative profiles of PBMC?\n* Can GLP-1 receptor agonists reverse inflammatory and oxidative alterations induced by plasma from patients with peripheral artery disease in endothelial cell cultures?\n* Are there specific plasma proteomic signatures associated with GLP1R overexpression?\n\nResearchers will compare patients with intermittent claudication to patients with chronic limb-threatening ischemia to see if disease severity is associated with differences in GLP1R expression, PBMC inflammatory\u002Foxidative phenotype, and plasma proteomic profiles.\n\nParticipants will:\n\n* Provide an additional blood sample (15 mL) collected during a routine, clinically indicated blood draw\n* Have PBMC isolated for measurement of GLP1R expression and assessment of inflammatory and oxidative markers\n* Have plasma analyzed for proteomic profiling and used in in-vitro endothelial cell experiments\n\nParticipation ends after completion of the blood sampling, and no additional procedures beyond standard clinical care are required.",[391,392,26],"Peripheral Arterial Disease (PAD)","Claudication, Intermittent",[343,244,394,395],"GLP-1 receptor","Peripheral blood mononuclear cells (PBMC)","2026-01-05",{"date":398,"type":44},"2026-01-14",{"date":400,"type":21},"2026-06",{"date":402,"type":21},"2028-06",{"name":404,"class":51},"University Hospital, Strasbourg, France",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":412,"sex":17,"minAge":413,"maxAge":209,"enrollmentInfo":414,"targetDuration":4,"studyType":139,"phases":416,"briefSummary":417,"conditions":418,"keywords":422,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":102},"100618362","chronic-wounds-and-blood-circulation-detection-100618362","NCT07330635","Chronic Wounds and Blood Circulation Detection","Constructing a Holistic Care New Model for Chronic Wounds and Blood Circulation Detection to Enhance Home Care Quality","Inclusion Criteria:\n\nGeneral criteria (applied to all participants):\n\nWillingness to participate in this study and comply with all study procedures. Able to perform basic physical activity and complete lower limb circulatory and functional assessments.\n\nNormal cognitive function sufficient to understand instructions and provide informed consent.\n\nGroup-specific criteria:\n\nYoung Adults (Control Group):Aged 20-40 years.No known chronic diseases or peripheral circulatory disorders.Considered healthy volunteers.\n\nOlder Adults (Healthy Elderly Group):Aged 65-95 years.No major chronic diseases affecting lower limb circulation.\n\nOlder Adults with Chronic Disease (Impaired Circulation Group):Aged 65-95 years.Diagnosed with one or more conditions known to impair peripheral circulation, including but not limited to peripheral arterial disease (e.g., atherosclerosis, thromboangiitis obliterans), chronic venous insufficiency (e.g., varicose veins), diabetes mellitus, hypertension, or hyperlipidemia.\n\nExclusion Criteria:\n\nRecent acute lower limb injury resulting in tissue exudation, swelling, or other conditions that prevent safe participation in the assessment or intervention procedures.",true,"20 Years",{"count":415,"type":21},425,[141],"Lower limb circulatory insufficiency and the associated chronic wounds are common health problems among the elderly. These issues not only affect the individual's mobility and quality of life but also potentially increase medical costs and caregiving expenses. Traditional treatment methods often employ medications to enhance blood circulation, but these clinical approaches have limited effectiveness and induce the risk of side effects. Utilizing exercise as an intervention strategy can help improve lower limb blood circulation in the elderly while reducing the side effects associated with medications. However, due to physical frailty, elderly individuals often cannot participate in high-intensity exercises to improve their circulatory performance.\n\nTherefore, this study will develop a lower limb circulation enhancement exercise system to improve the circulatory performance in individuals with poor lower limb circulation. It will compare the effects of lower limb circulation enhancement exercise, vibration exercise, and mixed exercise on improving blood circulation and functional performance in the elderly or individuals with poor lower limb circulation.\n\nParticipants will be randomly assigned into three groups: the lower limb circulation enhancement exercise group, the vibration exercise group, and the mixed exercise group. In addition, a separate group of young adults (control group) will serve as a reference for baseline comparisons. Initially, all participants will undergo a one-time exercise test, followed by a 12-week intervention. The lower limb circulation enhancement exercise group will perform a 30-minute leg press rowing exercise three times a week, while the vibration exercise group will engage in vibration exercise at the same frequency, and the mixed exercise group will perform group-based mixed exercise training at the same frequency. The young adult control group will not receive any intervention but will undergo the same assessments.\n\nOutcome evaluations before and after the intervention include lower limb blood perfusion monitoring, pain scales, and functional performance assessments.",[419,420,26,421],"Aging","Walking, Difficulty","Chronic Disease",[423,424,421],"Poor Lower Limb Circulation","Older Adults","2025-12-29",{"date":427,"type":44},"2026-01-09",{"date":429,"type":44},"2024-09-04",{"date":431,"type":21},"2027-12-31",{"name":433,"class":51},"National Health Research Institutes, Taiwan",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":441,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":139,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":102},"100583687","pressure-wire-guidance-for-infrapopliteal-artery-interventions-100583687","NCT06879561","Pressure Wire Guidance for Infrapopliteal Artery Interventions","Impact of Pressure Wire-guidance Versus Angiography-guidance for Infrapopliteal Artery Interventions on Post-procedural Perfusion Status and Wound Healing in Patients With Chronic Limb Threatening Ischemia (PERFECT-CLI)","Inclusion Criteria:\n\n* Patient with chronic limb threatening ischemia (Rutherford 5)\n* Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years\n\nExclusion Criteria:\n\n* Acute limb ischemia\n* Contraindication to antiplatelet or anticoagulation agents:\n\n  1. Thrombocytopenia (platelet \\\u003C100,000\u002FuL)\n  2. Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months\n* Pregnant women or women with potential childbearing\n* Life expectancy \\\u003C 1 year","19 Years",{"count":211,"type":21},[141],"\"• A prospective, single-center randomized controlled comparison trial.\n\n* A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria.\n* Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group.\n* Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions.\n* In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \\>50% or flow-limiting dissection.\n* In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire.\n* The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure.\n* Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events.\"",[26],"2025-11-30",{"date":448,"type":44},"2025-12-02",{"date":450,"type":44},"2025-10-02",{"date":452,"type":21},"2028-08-29",{"name":454,"class":51},"Yonsei University",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":102},"100536439","peripheral-bypass-trial-for-completion-control-100536439","NCT06264843","Peripheral Bypass Trial for Completion Control","Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia (CLTI) Patients","PATENT","Inclusion Criteria:\n\n* Chronic Limb-Threatening Ischemia as defined by presence of Peripheral Artery Disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration\\>2 weeks duration (ref Global Guidelines)\n* Atherosclerotic infra-popliteal PAD\n* Adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic\u002Foccluded segment.\n* Available autogenous vein conduit based on preoperative vein mapping.\n* Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.\n\nExclusion Criteria:\n\n* Bypass with artificial conduit or cryopreserved allografts\n* Bypass for non-atherosclerotic lesions\n* Life-expectancy less than 2 years\n* Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.\n* Any condition that the investigator believes should exclude participation.\n* Excessive risk for adverse events during open surgery as judged by the investigator.",{"count":464,"type":21},450,"The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle",[26],[28],"2025-10-13",{"date":470,"type":44},"2025-10-14",{"date":472,"type":44},"2024-11-14",{"date":474,"type":21},"2027-12",{"name":476,"class":153},"Medistim ASA",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":412,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":139,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100602211","outcomes-of-atherectomy-and-balloon-angioplasty-compared-to-conventional-angioplasty-in-infra-popliteal-chronic-limb-threatening-ischemia-100602211","NCT07120555","Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia","Inclusion Criteria:\n\nAll patients present with CLTI due to isolated infra-popliteal disease with the following criteria:\n\n* Denovo or Recoil\n* Reference tibial vessel diameter at least (2mm)\n* The diseased tibial artery has a patent distal segment supplying the foot\n\nExclusion Criteria:\n\n* Patients present with:\n\n  * Previous ipsilateral infrapopliteal bypass surgery\n  * Concomitant iliac or femoral artery lesion\n  * Isolated pedal arch disease\n  * previous atherectomy\n  * Faliure to cross the lesion\n  * Known hypercoagulable disorder or non-atherosclerotic vasculopathy\n  * Severe renal insufficiency (eGFR \\\u003C30) not on dialysis",{"count":484,"type":21},60,[141],"Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of amputation if left untreated. Infra-popliteal arteries are frequently involved in CLTI, especially in diabetic and elderly patients, posing significant challenges due to diffuse, calcified, and long-segment occlusive lesions.\n\nConventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial.\n\nGiven the growing use of endovascular therapies, a comparative analysis of outcomes between combined atherectomy-balloon angioplasty and conventional angioplasty in infra-popliteal interventions is essential to guide evidence-based management in CLTI patients.",[25],"2025-08-12",{"date":490,"type":44},"2025-08-13",{"date":492,"type":21},"2025-09-30",{"date":494,"type":21},"2027-12-30",{"name":302,"class":51},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":387,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":139,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":102},"100598230","revascularization-of-single-vesrus-multiple-infrapopliteal-vessels-in-chronic-limb-threatening-ischemia-100598230","NCT07068789","Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia","Revascularization of Single Versus Multiple Infrapopliteal Vesseles in Chronic Limb Threatening Ischemia : Limb Salvage Rate","Inclusion Criteria: 1. patients aged 40 years or older 2. patients with Rutherford category \"4\" and \"5\" 3. patients with angiographic evidence of infrapopliteal vessel occlusive disease -\n\nExclusion Criteria:\n\n1. patients who refuse to participate in the study\n2. patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement\n3. patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -",{"count":84,"type":21},[141],"This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period",[25,507],"Infrapopliteal Arterial Occlusive Disease",[509,510,511,90],"chronic limb threatening ischemia","infrapopliteal arteries angioplasty","limb salvage","2025-07-07",{"date":514,"type":44},"2025-07-16",{"date":516,"type":44},"2025-06-25",{"date":518,"type":21},"2025-09-25",{"name":520,"class":51},"Sohag University",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":529,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":139,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":102},"100536322","the-roamm-ehr-study-100536322","NCT06263322","The ROAMM-EHR Study","ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients","ROAMM-EHR","Inclusion Criteria:\n\n* age \\>= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery \\[endovascular or open re-vascularization (bypass)\\].\n\nExclusion Criteria:\n\n* High risk of post-surgical amputation based on study physician judgement, non-english speaker, diagnosis of an age-related dementia (e.g. Alzheimer's Disease); unable to communicate because of severe hearing loss; uncorrectable vision impairment that compromises clinical assessments or would cause a safety concern, other significant co-morbid disease that in the opinion of the investigators and study physician would impair the ability to participate in the study or be a safety concern","60 Years","100 Years",{"count":291,"type":21},[141],"In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.",[115,26],"2025-06-24",{"date":537,"type":44},"2025-06-27",{"date":539,"type":44},"2023-11-16",{"date":541,"type":21},"2026-10-17",{"name":543,"class":51},"University of Florida",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":553,"studyType":22,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":102},"100594056","efficacy-of-the-ranger-drug-coated-balloon-in-treating-btk-lesions-in-patients-with-clti-100594056","NCT07014475","Efficacy of the Ranger Drug-Coated Balloon in Treating BTK Lesions in Patients With CLTI","Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender is not limited\n2. The patient agreed to participate in the CEIBA study and signed the written informed consent\n3. Diagnosis of chronic limb-threatening ischemia (Rutherford category 4-6)\n4. Gangrene involving any part of the lower extremities or feet, with exclusion of patients who have:\n\n   4.1 Pure venous ulcers 4.2 Pure traumatic wounds 4.3 Acute limb ischemia (symptoms present for 2 weeks or less) 4.4 Embolic disease 4.5 Non-atherosclerotic chronic lower extremity vascular diseases (e.g., vasculitis, Buerger's disease, radiation arteritis)\n5. Outflow Tract Requirement: At least one direct or indirect, unobstructed outflow vessel in the submalleolar segment of the target limb planned for revascularization.\n6. Lesion Type:\n\n6.1 Unobstructed blood flow in the suprapopliteal access pathway (including inflow vessels that have been recanalized via staged or concurrent endovascular intervention or hybrid surgery).\n\n6.2 Sub-knee stenotic lesions ≥ 5 cm in length with ≥ 70% diameter reduction. 6.3 Sub-knee occlusive lesions ≥ 1 cm in length. 6.4 Two separate lesions with a minimum 3 cm interval between them may be considered as a single lesion for study inclusion purposes.\n\nExclusion Criteria:\n\n1. Presence of life-threatening diseases or comorbidities with an expected life expectancy of less than 1 year.\n2. Concurrent participation in another interventional clinical trial requiring informed consent.\n3. Diagnosis of Alzheimer's disease.\n4. Hematologic disorders or known bleeding tendency.\n5. Contraindications to antiplatelet or anticoagulant therapy.\n6. Known allergy to contrast agents that cannot be managed with standard premedication (e.g., steroids).\n7. Deficiency or dysfunction of protein C, protein S, or antithrombin III (ATIII).\n8. New York Heart Association (NYHA) Class III or IV heart failure.\n9. Pregnancy or lactation.\n10. Prior suprapatellar or infrapatellar amputation of the target limb.\n11. Presence of aneurysm, perforation, dissection, or other target vessel injury requiring intervention.\n12. Presence of other comorbid conditions (unrelated to the index disease) that affect walking function.\n13. History of cardiovascular events within the past 3 months, including nonfatal myocardial infarction, unstable angina, stable angina, nonfatal ischemic stroke, or hemorrhagic stroke.\n14. Clinically significant liver or renal dysfunction, as determined by the investigator.\n15. Any other condition that, in the opinion of the investigator, would interfere with study treatment or functional assessments.",{"count":552,"type":21},700,"6 Months","This is a prospective, multicenter, observational study designed to evaluate the clinical outcomes of the Ranger™ SL paclitaxel-coated balloon, a type of drug-coated balloon (DCB), in the treatment of below-the-knee (BTK) lesions in patients with chronic limb-threatening ischemia (CLTI) in China. All enrolled patients will be followed for six months. Patients diagnosed with CLTI who undergo treatment with the Ranger DCB will be included in the study. The primary outcome is the incidence of major adverse events (MAEs).",[25],[509,557,558],"below the knee","drug-coated balloon","2025-06-03",{"date":561,"type":44},"2025-06-11",{"date":563,"type":21},"2025-06-30",{"date":565,"type":21},"2029-01-01",{"name":567,"class":51},"First Affiliated Hospital, Sun Yat-Sen University",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":412,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":139,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":102},"100333517","radiotracer-based-perfusion-imaging-of-patients-with-peripheral-arterial-disease-100333517","NCT03622359","Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease","Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease","Inclusion Criteria for Patients with Peripheral Artery Disease:\n\n1. At least 18 years of age\n2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.\n\nExclusion Criteria for Patients with Peripheral Artery Disease:\n\n1. Unable to give informed consent or follow-up\n2. Pregnant or nursing\n3. Under the age of 18\n4. No history of peripheral artery disease\n\nInclusion Criteria for Healthy Control Subjects:\n\n1. At least 18 years of age\n2. No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.\n\nExclusion Criteria for Healthy Control Subjects:\n\n1. Unable to give informed consent of follow-up\n2. Pregnant or nursing\n3. Under the age of 18\n4. History of peripheral artery disease",{"count":576,"type":21},192,[141],"The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.",[317,580,26],"Diabetes Mellitus",[582,583,584,585],"Radionuclide imaging","Perfusion imaging","Positron emission tomography","Single photon emission computed tomography","2025-03-27",{"date":588,"type":44},"2025-04-01",{"date":590,"type":44},"2017-02-17",{"date":199,"type":21},{"name":593,"class":51},"Nationwide Children's Hospital",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":102},"100570946","angioplasty-with-shockwave-ivl-catheter-system-in-femoropopliteal-lesions-100570946","NCT06713850","Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions","Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries","SHIELD","Inclusion Criteria:\n\n\\-\n\n1\\) Age ≥ 18 years (2) Rutherford Classification 2-5 3) Stenosis (\\>70% stenosis confirmed by digital subtraction angiography (DSA) imaging) or occlusion of the femoropopliteal artery, with one healthy patent outflow tract distal to the knee in continuity with a patent outflow tract below the ankle.\n\n(4) Patients who understand the purpose of the study, participate in the experiment voluntarily, sign the informed consent form and are willing to be followed up.\n\n5\\) The guidewire needs to pass through the lesion; 6) Life expectancy \\>24 months 7) Moderately severe calcified lesions confirmed by imaging data: 8) For patients who receive intervention in both lower extremities may be enrolled in order of time of intracavitary treatment 9) For combined aortoiliac artery lesions that have undergone endoluminal revascularization to achieve flow recanalization without more than 50% residual stenosis.\n\nExclusion Criteria:\n\n1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment (2) Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.\n\n3\\) Patients who have been enrolled in medications that interfere with this clinical trial within the last 3 months or who have been treated intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, and so on; 4) Pregnant and lactating women 5) Patients who are unable or unwilling to participate in this trial. 6) patients with Berger's disease 7) patients who have received arterial bypass diversion on the treated side",{"count":603,"type":21},130,"There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.",[606,25],"Peripheral Artery Disease (PAD)",[317,25,608],"Severe calcification","2024-11-27",{"date":611,"type":44},"2024-12-03",{"date":613,"type":21},"2024-12-01",{"date":615,"type":21},"2028-11",{"name":330,"class":51},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":412,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":626,"conditions":627,"keywords":628,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":102},"100499649","multimodal-noninvasive-assessment-of-peripheral-circulation-in-chronic-limb-threatening-ischemia-100499649","NCT05786001","Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia","Evaluation of Lower Limb Angiosome Perfusion and Oxygenation Using Thermal and Hyperspectral Imaging","Inclusion Criteria:\n\n* for CLTI patients age \\>50\n* for age control group age \\>50 and not diagnosed with cardiovascular diseases. 0.9 \\\u003C ABI \\\u003C 1.3\n* for healthy group 18 \\\u003C= age \\\u003C= 50 and no history of cardiovascular disease\n* volunteering for study\n\nExclusion Criteria:\n\n* inability to give informed consent\n* denial",{"count":625,"type":21},150,"Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy and unhealthy individuals.",[25],[629,630,631,28,632],"hyperspectral imaging","thermal imaging","angiosomes","diabetes","2024-06-18",{"date":635,"type":44},"2024-06-20",{"date":637,"type":44},"2024-06-17",{"date":639,"type":21},"2025-12-31",{"name":641,"class":51},"Tampere University"]