[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"critical-limb-ischemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:critical-limb-ischemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,42,71,102,123,147,175,198,222,247,266,289,310,327,352,374,411,434,458,481,503,525,550,570],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100557901","use-of-thermal-imaging-camera-to-assess-perfusion-before-and-after-vascular-intervention-100557901",false,"NCT06544135","Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention","TIC","Inclusion Criteria:\n\n* Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.\n* Planned lower extremity endovascular intervention\n\nExclusion Criteria:\n\n* Non-arterial ulcers\n* Pregnant","ALL","18 Years","99 Years",{"count":20,"type":21},25,"ESTIMATED","1 Year","OBSERVATIONAL","This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.\n\nThe main question this study aims to answer is:\n\n\\- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?",[26,27,28],"Peripheral Arterial Disease","Critical Limb Ischemia","Critical Lower Limb Ischemia","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-04-14",{"date":37,"type":21},"2027-10",{"name":39,"class":40},"University Hospitals Cleveland Medical Center","OTHER",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100326360","early-phase-1-nutrition-in-patient-with-critical-limb-ischemia-100326360","NCT03529019","Nutrition in Patient With Critical Limb Ischemia","Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia","NutriVasc","Inclusion Criteria:\n\n* Critical Limb Ischemia\n\nExclusion Criteria:\n\n* Female patients who are pregnant or lactating\n* Chronic Kidney Disease Stages 4 and 5\n* Patients who are on dialysis",{"count":51,"type":21},30,"INTERVENTIONAL",[54],"EARLY_PHASE1","A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.",[27,57,58],"Malnutrition","Nutritional Supplements",[60],"Enhanced Recovery After Surgery Protocol","2026-06-29",{"date":63,"type":33},"2026-06-30",{"date":65,"type":33},"2018-10-02",{"date":67,"type":21},"2026-09",{"name":69,"class":40},"Boston Medical Center",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":52,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":70},"100540586","predictive-value-of-systolic-rise-time-of-the-plantar-arch-on-the-risk-of-major-adverse-limb-events-male-and-major-adverse-cardiovascular-events-mace-in-peripheral-artery-disease-pad-at-critical-ischaemia-stage-100540586","NCT06318767","Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage","TAMIS","Inclusion Criteria:\n\n* patients at least 18 years old,\n* willing and able to provide written informed consent,\n* with documented atherosclerosis critical limb ischemia (pain rest and\u002For ulcer and gangrene manifestations)\n* with hemodynamic measures (ankle pressure less than 50mmHg and\u002For TBI less than 30mmHg and\u002For TcPO2 less than 30 mmHg),\n* followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.\n\nExclusion Criteria:\n\n* with non atherosclerosis arteriopathy,\n* ineligible to the gold standard treatment such as the chirurgical revascularization,\n* with life expectancy less than 3 months.",{"count":79,"type":21},134,[81],"NA","Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).\n\nIt is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).",[84,85,86,27,87],"Major Adverse Limb Events","Major Adverse Cardiovascular Events","Peripheral Artery Disease","Hemodynamic Measure",[89,90,91,92,93],"major adverse limb events","major adverse cardiovascular events","peripheral artery disease","critical limb ischemia","hemodynamic measure","2026-06-12",{"date":96,"type":33},"2026-06-15",{"date":98,"type":33},"2024-03-07",{"date":67,"type":21},{"name":101,"class":40},"Centre Hospitalier Universitaire, Amiens",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":52,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":70},"100366695","faza-petmri-in-cli-patients-pre-and-post-revascularization-100366695","NCT04054609","FAZA PET\u002FMRI in CLI Patients Pre and Post Revascularization","Evaluation Of Prognostic Value of 18f-Fluoroazomycin Arabinoside (FAZA) Positron Emission Tomography\u002FMagnetic Resonance Imaging (PET\u002FMR) In Patients With Critical Limb Ischemia Pre- and Post Revascularization: a Pilot Study","Inclusion Criteria:\n\n* Age \\>= 18 years;\n* Patients with clinical evidence of critical limb ischemia that are candidates for revascularization treatment;\n* A negative urine or serum pregnancy test in women of child-bearing age;\n* Ability to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Contraindication for MR as per current institutional guidelines;\n* Inability to lie supine for at least 30 minutes;\n* Pregnant or breastfeeding;\n* Unable or unwilling to provide informed consent;\n* Impending amputation within 6 weeks of presentation;\n* Previous metallic hardware in the lower limbs;\n* Unable to have ethanol.",{"count":110,"type":21},40,[81],"Peripheral artery disease is a worldwide problem, leading to high mortality and mobility.\n\nCritical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality. Endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations.\n\nIn recent years, development of molecular imaging tools are now become available. A recent radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) its an specific marker of hypoxia in the tissues and has been used in multiples studies. This tracer can be used in PET\u002FMR scan providing a potentially power diagnostic tool in patients with CLI, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. This diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients.\n\nMoreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. We will try to find some predictor model in the FAZA PET\u002FMR that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases.\n\nThirdly, post processing for optimization of the MR sequences in patients with CLI will be performed at the MR component of the PET. There would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.",[27],"2026-06-08",{"date":116,"type":33},"2026-06-10",{"date":118,"type":33},"2019-08-31",{"date":120,"type":21},"2027-12",{"name":122,"class":40},"University Health Network, Toronto",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":52,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":70},"100640911","local-and-systemic-macrophage-activation-in-coronary-and-peripheral-artery-disease-100640911","NCT07588295","Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease","Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease: the LAST-COP Study","Inclusion Criteria:\n\n* Patients with chronic coronary artery disease;\n* Patients with no-ST elevation acute coronary syndrome;\n* Patients with chronic claudication (Rutherford II-III)\n* Patients with critical limb ischemia (Rutherford IV-V).\n\nExclusion Criteria:\n\n* Severe renal dysfunction\n* Severe valve disease\n* Advanced heart failure\n* Advanced liver disease\n* Chronic inflammatory or autoimmune disease\n* Use of antinflammatory drugs\n* Acute infection\n* Recent surgical procedures",{"count":131,"type":21},60,[81],"Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.\n\nThis study aims to evaluate and compare the presence of macrophages and their subsequent activation within coronary and peripheral atherosclerotic lesions, and to correlate these findings with the distribution of circulating monocyte subpopulations.",[135,136,27,137],"Stable Coronary Artery Disease","Acute Coronary Syndromes","Intermittent Claudication","2026-05-11",{"date":140,"type":33},"2026-05-14",{"date":142,"type":33},"2024-03-18",{"date":144,"type":21},"2026-12",{"name":146,"class":40},"Maria Cecilia Hospital",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":52,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":51},"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":156,"type":21},100,[81],"A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.",[27,160,26],"Chronic Limb-Threatening Ischemia",[162,163,164],"CLTI","PAD","CLI","2026-04-13",{"date":167,"type":33},"2026-04-16",{"date":169,"type":33},"2022-12-22",{"date":171,"type":21},"2027-05-01",{"name":173,"class":174},"LimFlow, Inc.","INDUSTRY",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":52,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100525533","drug-eluting-temporary-spur-stent-system-vs-percutaneous-balloon-angioplasty-for-the-treatment-of-critical-limb-ischemia-100525533","NCT06122974","Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia","A RanDomized Controlled Trial of the Drug Eluting TEmporary Spur StEnt System vs PERcutaneous Balloon Angioplasty for the TReatment of CriTical Limb Ischemia","DEEPER RCT","Inclusion Criteria:\n\nPre-Procedure Inclusion Criteria:\n\n1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.\n2. Life expectancy greater than 1 year in the investigator's opinion.\n3. Subject is greater than 18 years of age.\n4. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and\u002For minor tissue loss (R5), 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.\n5. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure.\n\nAngiographic Inclusion Criteria:\n\n1. Stenotic, restenotic, or occlusive lesions with greater than or equal to 70% stenosis located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire via the true lumen.\n2. Iliac, Superficial Femoral Artery (SFA) and popliteal inflow lesions can be treated using standard of care during the index procedure\n\n   Note:\n   1. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.\n   2. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not severely fractured or otherwise compromised.\n   3. Distal embolic protection is strongly encouraged in cases where atherectomy is used.\n   4. Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.\n   5. Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to randomization.\n3. Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.\n\n   Note:\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.\n   3. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and\u002For plantar arteries.\n4. Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.\n5. Target vessel reference diameter is measured to be greater than or equal to 2.5 and less than or equal to 4.25 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site (visual estimate permitted):\n\n   1. Intravascular Ultrasound (IVUS)\n   2. Quantitative Vascular Angiography (QVA)\n   3. Visual Estimate\n6. Target lesion length must be less than or equal to 210 mm cumulatively. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.\n7. Only one limb and one vessel may be enrolled per subject. If the investigator feels that multiple infrapopliteal vessels must be treated during the index procedure, a standard practice treatment may be performed in the non-target infrapopliteal vessel(s). This should be prior to randomization of and treatment of the target vessel whenever possible.\n\n   Note:\n   1. Distal embolic protection is strongly recommended in cases using atherectomy.\n   2. Treatment of the target vessel\u002Flesion 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.\n   3. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.\n8. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the randomized treatment must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.\n\nExclusion Criteria:\n\nPre-procedure Exclusion Criteria:\n\n1. Subject unwilling or unlikely to comply with the 5-year duration of the study 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 systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.\n5. Subject has osteomyelitis proximal to the phalanges of the target foot. Osteomyelitis in the digit(s) of the target foot is permitted.\n6. Wounds in the target limb must be confined to the foot below the ankle.\n7. Heel wounds on the target foot are excluded; wounds on the plantar surface of the hindfoot are permitted.\n8. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) amputation) is permitted.\n9. Myocardial infarction (MI) or stroke within 90 days of the index procedure.\n10. Symptomatic acute heart failure New York Heart Association (NYHA) class III or greater.\n11. Impaired renal function (estimated Glomerular Filtration Rate (eGFR) less than or equal to 25 mL\u002Fmin) within 30 days of procedure or end stage renal disease on dialysis.\n12. Subject with vasculitis or uncontrolled clotting disorder that may preclude patient to thrombotic events.\n13. Inability to tolerate dual antiplatelet and\u002For anticoagulation therapy, including a history of severe bleeding or coagulopathy.\n14. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, drug balloon coatings and their excipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.\n15. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.\n16. Known allergy to nitinol or nickel.\n17. Bypass surgery of the target vessel. Prior bypass above the level of the infrapopliteal arteries is permitted.\n\nAngiographic Exclusion Criteria\n\n1. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of unstable or flow limiting aneurysmal segments.\n2. Fractured or otherwise compromised stents or dissection repair devices in the target vessel or inflow vessel.\n3. In-stent restenosis in the target vessel, including restenosis of dissection repair devices.\n4. Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.\n5. Angiographic evidence of thrombus within target limb.\n6. Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.\n7. Flow-limiting dissection incurred during lesion crossing\n8. Significant (greater than or equal to 70%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.\n9. Distance from access to lesion is too long for 135 cm working length of catheter.",{"count":184,"type":21},518,[81],"The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.\n\nThe Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.",[27],"NOT_YET_RECRUITING","2026-01-05",{"date":191,"type":33},"2026-01-07",{"date":193,"type":21},"2026-08",{"date":195,"type":21},"2037-12",{"name":197,"class":174},"ReFlow Medical, Inc.",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100450437","crush-pad-real-world-outcomes-following-use-of-shockwave-intravascular-lithotripsy-ivl-technology-in-calcified-common-femoral-lesions-100450437","NCT05145478","CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","Inclusion Criteria:\n\n* Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs\n* Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines\n* Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.\n\nAngiographic Inclusion Criteria\n\n* Target lesion that is located in a native, de novo common femoral artery\n* Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.\n* Target lesion is ≥70% stenosis by investigator via visual estimate.\n* Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.\n* Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.\n* Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \\> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \\\u003C50mm in length.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.\n* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.\n* Cognitive impairment as documented in medical records\n* Not speaking English or Spanish\n* Currently a prisoner\n* Pregnancy or nursing\n* Estimated survival less than 12 months at the time of screening\n* Prior history of CFA endarterectomy",{"count":206,"type":21},50,"The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.",[209,26,210,27],"Femoral Arterial Calcification","Claudication",[86],"2025-11-03",{"date":214,"type":33},"2025-11-05",{"date":216,"type":33},"2021-12-01",{"date":218,"type":21},"2027-06-01",{"name":220,"class":40},"Yale University",2,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":52,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":245,"locationsCount":70},"100504921","phase-4-efficacy-and-safety-of-stempeucel-in-patients-with-critical-limb-ischemia-cli-due-to-buergers-disease-100504921","NCT05854615","Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease","An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease","Inclusion Criteria:\n\n1. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.\n2. Buerger's disease as diagnosed by Shionoya criteria\n3. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive)\n4. Ankle Brachial Pressure Index (ABPI) ≤ 0.6. If ABPI is ≥ 1.1 then Toe Brachial Index (TBI) will be performed and TBI should be ≤ 0.5\n5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits\n\nExclusion Criteria:\n\n1. Patients diagnosed with atherosclerotic peripheral arterial disease\n2. Patients eligible for surgical or percutaneous revascularization\n3. Patients with a history of participating in another stem cell trial or therapy within 3 months\n4. Patients who are unsuitable to participate the clinical trial as determined by investigators","65 Years",{"count":41,"type":21},[232],"PHASE4","The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease. The main questions it aims to answer are:\n\n* Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to Buerger's disease while improving the healing rate and functional outcomes?\n* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to Buerger's disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.",[27,235],"Buerger's Disease",[92,237,238],"Buerger's disease","bone marrow derived mesenchymal stem cell","2025-09-08",{"date":241,"type":33},"2025-09-09",{"date":243,"type":33},"2024-01-01",{"date":120,"type":21},{"name":246,"class":174},"Cell Biopeutics Resources Sdn Bhd",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":254,"targetDuration":4,"studyType":52,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":265,"locationsCount":70},"100504923","phase-4-efficacy-and-safety-of-stempeucel-in-patients-with-critical-limb-ischemia-cli-due-to-peripheral-arterial-disease-100504923","NCT05854641","Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease","An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease.","Inclusion Criteria:\n\n* Patients between 18-65 years old\n* Patients diagnosed with atherosclerotic peripheral arterial disease\n* Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients)\n* Patients with at least one ulcer (between 0.5 to 10 cm2 size)\n* Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5)\n* Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations\n\nExclusion Criteria:\n\n* Patients diagnosed with Buerger's disease by Shionoya criteria\n* Patients eligible for surgical or percutaneous revascularization\n* Patients with a history of participating in another stem cell trial or therapy within 3 months\n* Patients who are unsuitable to participate the clinical trial as determined by investigators",{"count":255,"type":21},10,[232],"The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are:\n\n* Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes?\n* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.",[27,26],[92,260,261],"peripheral arterial disease","bone marrow-derived mesenchymal stem cell",{"date":241,"type":33},{"date":243,"type":33},{"date":120,"type":21},{"name":246,"class":174},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":52,"phases":276,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":221},"100395782","phase-3-temsirolimus-adventitial-delivery-to-improve-angioplasty-andor-atherectomy-revascularization-outcomes-below-the-knee-100395782","NCT04433572","Temsirolimus Adventitial Delivery to Improve ANGioplasty and\u002For Atherectomy Revascularization Outcomes Below the Knee","Temsirolimus Adventitial Delivery to Improve ANGioplasty and\u002For Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg\u002FmL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease","TANGO-3","Inclusion Criteria\n\nPre-procedural:\n\n1. Participant has signed and dated informed consent, is capable of understanding the nature, significance and implications of the clinical trial, and is willing to comply with all study procedures and follow-up visits for the duration of the study.\n2. Participant is male or female, aged 18 years or older.\n3. If participant is female and of reproductive potential: agreement to use a highly effective contraception (abstinence is acceptable) for at least 90 days after study treatment.\n4. Participant has severe claudication (Rutherford 3) or chronic limb-threatening ischemia (CLTI) (Rutherford 4-5) in the Target Limb.\n\n   Angiographic\u002FProcedural:\n5. Participant has up to two de novo or restenotic Qualified Target Lesions meeting the following criteria, each based on the Investigator's visual assessment. Target Lesions should be considered separate if they are located in separate vessels (not in the same blood path) or have more than 10 cm intervening normal artery.\n\n   Diameter\n   1. ≥70% diameter stenosis anywhere within the Target Lesion or ≥50% diameter stenosis spanning at least 10 cm of length.\n   2. Reference (normal) vessel diameter ≥2 mm and ≤8 mm. Location\n   3. Any lesion chosen as a Target Lesion is in or spans at least one below-knee popliteal (P3 segment), tibial, or peroneal artery and is a culprit for dominant disease symptoms based on Investigator's assessment.\n   4. ≥50% of the Target Lesion length is below the knee joint space (\\\u003C50% of Target Lesion length may extend above the midline of the knee joint space).\n   5. ≥10 mm away from any previously placed stent or graft.\n   6. A Target Lesion may cross an ostium of another artery (i.e. pass a bifurcation) but may only include one of the two branches. (Notes: Investigator should choose the dominant lesion for Target Lesion. Bifurcated lesions should be excluded, but if a lesion in a bifurcating vessel is separate from a Target Lesion based on intervening normal artery from which a proximal reference diameter can be measured, it may be treated as a second Target Lesion.) Length\n   7. ≤30 cm in cumulative length from most proximal to most distal normal segment bounding the Target Lesion(s).\n   8. A single Target Lesion may be comprised of multiple lesions or multifocal lesions (i.e. tandem lesions) if there is no continuous normal segment \\>10cm in length within the Target Lesion.\n   9. Target Lesion may be in a vessel with another Target Lesion or above-knee non-target lesion if it is \\>10 cm away.\n6. Participant receives successful revascularization, based on the following Investigator visual assessments:\n\n   1. Target Lesion and any treated non-target lesion in a Target Vessel or its inflow has \\\u003C30% residual stenosis, outflow has \\\u003C50% stenosis, and there is no flow-limiting dissection or perforation after treatment in an inflow vessel or Target Vessel.\n   2. Participant has distal run-off into the foot with a patent named pedal artery.\n\nExclusion Criteria\n\nPre-procedural:\n\n1. Participant is already enrolled in another clinical study of systemic or local vascular drug therapy or a vascular device study that has not completed its primary endpoint, including prior enrollment in this study.\n2. Participant is pregnant, nursing, or planning to become pregnant during the first 12 months after their enrollment in the study.\n3. Participant has presence of another anatomic or comorbid condition, or other medical, social, or psychological condition that, in the investigator's opinion, could limit the participant's ability to complete the clinical investigation or comply with follow-up requirements.\n4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.\n5. Participant has a life expectancy of ≤1 year.\n6. Participant received in the prior 2 months, is currently receiving, or is planned to receive systemic immunosuppressive therapy, immunotherapy or chemotherapy.\n7. Participant has platelet count \\\u003C 100,000 cells per microliter or \\> 700,000 cells per microliter, or hemoglobin \\\u003C 7.5 g\u002FdL.\n8. Participant is unable to receive H1 antihistamine, temsirolimus or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions except for contrast allergies for which adequate prophylaxis may be used.\n9. Participant has a CNS tumor.\n10. Participant has had a myocardial infarction within the 30 days prior to study procedure.\n11. Participant has had a cerebrovascular accident within the 90 days prior to the study procedure.\n12. Participant has had an intracerebral hemorrhage within the 1 year prior to the study procedure.\n13. Participant has had any vascular surgical or endovascular procedure performed within the 30 days prior to the Index Procedure or planned within the 30 days after the Index Procedure; allowable exceptions to this exclusion include the following:\n\n    1. Procedures performed during the same setting as the Index Procedure.\n    2. Prior staged revascularization in the Target Limb but not the Target Lesion (e.g. for inflow revascularization) within the 30 days prior to the Index Procedure.\n14. Participant has a patent, previously implanted bypass graft within 3 cm of the Target Lesion.\n15. Participant is bedridden or unable to walk (with assistance is acceptable). Participants in wheelchair who are able to mobilize on their own can be enrolled.\n16. Participant has a planned major (above the ankle) amputation in the Target Limb.\n17. Participant has had any amputation to the ipsilateral extremity other than the toe or forefoot, or has had major amputation to the contralateral extremity \\\u003C 1 year prior to index procedure and is not independently ambulating.\n18. Participant has signs or symptoms of advanced limb infection or septicemia (fever \\> 38.5℃, white blood cell count \\> 15,000 cells per microliter, hypotension) at the time of assessment. Osteomyelitis of the phalanges or metatarsal heads or cellulitis of the foot amenable to treatment with IV antibiotics at the time of revascularization is acceptable.\n19. Participant has extensive tissue loss salvageable only with complex foot reconstruction or non-traditional amputations (e.g. Chopart or Lisfranc extending more proximal than a traditional transmetatarsal amputation), including any of the following conditions:\n\n    1. Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.\n    2. Any of the following involving the plantar skin of the forefoot, midfoot, or heel that cannot be effectively removed with a transmetatarsal amputation:\n\n    i) Gangrene. ii) Deep ulcer (penetrating deeper than the dermis to subcutaneous structures involving facia, muscle or tendon).\n\n    iii) Large shallow ulcer (not penetrating deeper than the dermis and \\>3cm in any measurement).\n\n    c) Full thickness heel ulcer with or without calcaneal involvement. d) Any wound with calcaneal bone involvement. e) Dorsal wound with extensive necrosis requiring planned amputation more proximal than a transmetatarsal amputation.\n\n    f) Wounds that are deemed to be neuropathic or non-ischemic in nature. g) Wounds that would require flap coverage or complex wound management for large soft tissue defect.\n20. Participant has a bilirubin level of \\>1.5xULN (upper limit of normal range).\n21. Participant has an estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin, except for patients with end stage renal disease on stable, chronic dialysis.\n\n    Angiographic\u002FProcedural:\n22. Participant has severe, advanced atherosclerotic peripheral artery disease (treated or left untreated) in the Target Limb which, in the opinion of the Investigator, has limited likelihood of a successful outcome.\n23. Participant has stenotic lesions, flow limiting dissection, or complication in any of the inflow or outflow vessels in the flow path of the Target Lesion, left untreated or after treatment, with residual stenosis \\>30% based on the Investigator's visual assessment.\n24. Participant receives or has received external radiation therapy to the target limb, vascular brachytherapy, cryotherapy, or drug-coated balloon (DCB) as part of the Target Lesion treatment during the index procedure or previous 6 months.\n25. Participant has been treated with a non-resorbable stent\u002Fscaffold in the Target Lesion in a prior setting (i.e. in-stent restenosis) or a bioresorbable scaffold in the Target Lesion in the previous 12 months.\n26. Participant has a severe (Type C or worse) dissection within the Target Lesion after revascularization but prior to Bullfrog drug delivery.\n27. Participant has an untreated aneurysm in the iliac, common femoral, superficial femoral, popliteal, or Target Vessel of the ipsilateral limb.\n28. Participant has visible thrombus requiring thrombolysis, percutaneous thrombectomy, or other treatment for acute limb ischemia of the Target Limb.\n29. Participant has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity upon completion of the intervention. (Pre- and post-angiographic imaging must confirm the absence of emboli in the distal anatomy.)\n30. Participant has a Target Lesion that cannot be crossed with a guide wire; however, subintimal wire crossing is allowed.\n31. Participant has heavy calcification at Target Lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall across the majority of the Target Lesion.",{"count":275,"type":21},250,[277],"PHASE3","A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg\u002FmL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.",[86,27],"2025-07-31",{"date":282,"type":33},"2025-08-05",{"date":284,"type":33},"2025-07-30",{"date":286,"type":21},"2032-08-01",{"name":288,"class":174},"Mercator MedSystems, Inc.",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":296,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":52,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":221},"100549451","serrantor-oct-study-100549451","NCT06434194","Serrantor OCT Study","Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)","Inclusion Criteria:\n\n* Rutherford clinical category 4-6 of the target limb\n* Age of subjects is \\>18 years old\n* Patients has given informed consent to participate in this study\n\nExclusion Criteria:\n\n* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion\n* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.\n* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.\n* Lesion length less than 220 mm","19 Years",{"count":131,"type":21},[81],"TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.",[27],"2025-05-14",{"date":303,"type":33},"2025-05-18",{"date":305,"type":33},"2024-10-31",{"date":307,"type":21},"2025-06-01",{"name":309,"class":174},"Cagent Vascular LLC",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":4},"100530780","effect-of-environmental-temperature-on-vascular-ultrasound-vein-scan-measurements-100530780","NCT06191237","Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements","Inclusion Criteria:\n\n* Inpatient at University Hospital Limerick under the care of a Vascular Consultant\n* Aged 18 years and above\n* Deemed suitable for two vascular ultrasound scans by the P.I\n\nExclusion Criteria:\n\n* Those unable to give informed consent\n* Aged under 18 years\n* Patients with varicose veins\u002Fvenous insufficiency",{"count":51,"type":21},"We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.",[27],"2025-04-30",{"date":321,"type":33},"2025-05-04",{"date":323,"type":21},"2025-09-01",{"date":323,"type":21},{"name":326,"class":40},"University Hospital of Limerick",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":335,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":70},"100521182","mirnas-in-critical-limb-ischemia-mirnacli-100521182","NCT06066268","miRNAs in Critical Limb Ischemia (miRNACLI)","Role of microRNAs in Critical Limb Ischemia","miRNACLI","Inclusion Criteria:\n\nCases:\n\n* patients affected by CLI candidates for popliteal exploration surgery and\u002For subgenual femoropopliteal bypass.\n* Patients affected by CLI with irreversible ischemia and\u002For distal gangrene of the lower limb candidates for major amputation of the lower limb.\n\nControls:\n\n• patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery of the AAA (EVAR) who are free from CLI, affected and not affected by type 2 diabetes mellitus.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients carriers of genetic diseases\n* Patients suffering from malignant neoplasia","40 Years","85 Years",{"count":338,"type":21},80,"For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling.\n\nThe results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.",[27],[342,343],"microRNA","Ischemia","2025-04-29",{"date":319,"type":33},{"date":347,"type":33},"2016-05-31",{"date":349,"type":21},"2026-05-31",{"name":351,"class":40},"IRCCS Policlinico S. Donato",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":52,"phases":361,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":70},"100553192","phase-2-tp03hn106-in-patients-with-critical-limb-ischemia-100553192","NCT06482892","TP03HN106 in Patients With Critical Limb Ischemia","A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia","Inclusion Criteria:\n\n1. When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender;\n2. Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6.\n3. Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week);\n4. During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery;\n5. During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb rest pain caused by lower limb ischemia, with a disease duration of ≥ 2 weeks, and a VAS score of ≥ 40mm and \\\u003C 100mm before the first administration; There are limb tissue ulcers caused by lower limb ischemia, with a disease duration of ≥ 2 weeks and limb ulcers (4cm2 ≤ maximum single ulcer area ≤ 25cm2);\n6. All subjects with fertility or their spouses must take effective contraceptive measures within 3 months after signing the informed consent form until the completion of the trial;\n7. The subjects voluntarily give informed consent and sign an informed consent form (if the subjects and\u002For their guardians lack reading ability and cannot understand the content of the informed consent, they need to sign together with a fair witness), fully understand the methods and procedures of the experiment, and be able to provide biological samples for testing related indicators in accordance with the experiment requirements.\n\nExclusion Criteria:\n\n1. Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products;\n2. Patients with limb gangrene greater than 4 cm2;\n3. Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured);\n4. Screening period for patients with liver and kidney failure:\n5. Patients who require hemodialysis;\n6. Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form;\n7. During the screening period, subjects with mental illness, obvious mental disorders or epilepsy, including other individuals with no behavioral or cognitive abilities;\n8. Hypertensive patients (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg) who cannot be controlled after standardized treatment in the screening period;\n9. Individuals who have received fresh plasma, cold precipitates, or blood products containing TP03HN106 components within one month prior to signing the informed consent form;\n10. Those who have participated in clinical trials of other drugs or medical devices within one month before signing the informed consent form;\n11. Those who have undergone or plan to undergo surgery during the trial period within one month prior to signing the informed consent form;\n12. Alcoholism and\u002For psychoactive substances, drug abusers and dependents (alcoholism standard: the weekly alcohol intake is more than 21 units (male) and 14 units (female) (1 unit=360 mL beer; or 150 mL wine; or 45 mL white spirit);\n13. Miscarriage or termination of pregnancy less than 3 months prior to signing the informed consent form, pregnant women and lactating women (currently breastfeeding or not artificially breastfeeding but less than 6 months after delivery);\n14. Poor compliance or any other situation that the researcher deems unsuitable for inclusion.",{"count":360,"type":21},15,[362],"PHASE2","Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.",[27],"2025-04-10",{"date":367,"type":33},"2025-04-15",{"date":369,"type":33},"2024-07-18",{"date":371,"type":21},"2025-12-30",{"name":373,"class":40},"Talengen Institute of Life Sciences, Shenzhen, P.R. China.",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":52,"phases":385,"briefSummary":386,"conditions":387,"keywords":396,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":221},"100331368","additional-hyperbaric-oxygen-after-lower-extremity-amputation-100331368","NCT03594344","Additional Hyperbaric Oxygen After Lower Extremity Amputation","Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial","AHOLEA","Inclusion Criteria:\n\n* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.\n* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist\u002FHyperbaric Medicine Physician.\n* Able to cooperate and follow up appointments\n* Included within 7 days after final surgery\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Pregnancy\n* Dementia","90 Years",{"count":384,"type":21},120,[81],"This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.",[388,389,27,390,391,392,393,394,395],"Diabetes Mellitus","Claudication, Intermittent","Osteomyelitis","Amputation","Lower Extremity Ulcer","Diabetic Angiopathy","Diabetic Neuropathies","Diabetic Foot",[397,398,399,400,401],"Diabetic foot","Diabetes","Lower extremity amputation","Hyperbaric oxygen therapy","HBOT","2025-03-25",{"date":404,"type":33},"2025-03-30",{"date":406,"type":33},"2018-07-04",{"date":408,"type":21},"2026-12-31",{"name":410,"class":40},"Oslo University Hospital",{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":419,"sex":16,"minAge":335,"maxAge":336,"enrollmentInfo":420,"targetDuration":4,"studyType":52,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":70},"100531779","early-phase-1-safety-tolerability-and-biodistribution-of-89zrzr-dfo-apac-in-subjects-with-paodcli-and-healthy-volunteers-acronyms-89zr--zirconium-89-dfo--desferrioxamine-apac--antiplatelet-anticoagulant-petct--positron-emission-tomographycomputed-tomography-100531779","NCT06204237","Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD\u002FCLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET\u002FCT = Positron Emission Tomography\u002FComputed Tomography)","Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Subjects With Peripheral Arterial Occlusive Disease \u002F Critical Limb Ischemia (PAOD\u002FCLI) and Healthy Volunteers - an Open Label PET Study (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET\u002FCT = Positron Emission Tomography\u002FComputed Tomography)","CHASE","INCLUSION CRITERIA PATIENTS\n\n1. Males and females aged 40-85 years.\n2. PAOD\u002FCLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1.\n3. Estimated glomerular filtration rate (eGFR) \\>46 mL\u002Fmin\u002F1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n4. CT angiography with contrast agent performed of within 3 months of the patients' first PET-scan as part of diagnostics of PAOD, with results available in the subject's medical records.\n5. No surgical or endovascular intervention for PAOD within 1 year of the first PET\u002FCT-scan or planned between inclusion and the patients' last PET-scan.\n6. Provision of valid informed consent and capability to communicate well with the investigator.\n7. Pre-menopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.\n8. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential.\n9. Patients should be able to understand all study-related information in Dutch.\n\nEXCLUSION CRITERIA PATIENTS\n\n1. Acute limb-threatening ischemia (e.g., embolic disease).\n2. An existing aneurysm that requires surgical intervention.\n3. Medical history of, or condition known to be associated with impaired hemostasis, such as an increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic stroke, or gastrointestinal or retroperitoneal bleeding, or any inherited or acquired bleeding disorder, such as von Willebrand disease or hemophilia.\n4. Any cerebrovascular event (including transient ischemic attack, thrombotic or embolic stroke) within the past year.\n5. Diagnosis of autoimmune (Type 1, or latent autoimmune diabetes in adults (LADA))diabetes mellitus.\n6. HbA1c \\>10% at screening.\n7. Current use of anticoagulant therapy (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason.\n8. Patients treated with combined antiplatelet agents, excluding a single agent, such as acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD).\n9. Use of non-steroidal anti-inflammatory medications within 2 weeks prior to dosing with \\[89Zr\\]Zr-DFO-APAC. If pain relief is required, paracetamol may be used.\n10. Use of selective serotonin reuptake inhibitor (SSRI) medications within 2 weeks prior to dosing with \\[89Zr\\]Zr-DFO-APAC.\n11. Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy or diagnostic angiography within the past 30 days prior to the screening visit.\n12. Uncontrolled arterial hypertension (persistent systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n13. Hemoglobin \\\u003C8.0 mmol\u002FL (130 g\u002Fl) (men) or \\\u003C7.5 mmol\u002FL (120 g\u002Fl) (women) at screening, or platelet count \\\u003C150 x 109\u002FL and leukocyte count \\>12 x 109\u002FL.\n14. Clinically significantly prolonged plasma prothrombin time (PT) and activated plasma partial thromboplastin time (APTT) (\\> 1.2-fold).\n15. Patients with a medical history of heparin-induced thrombocytopenia.\n16. Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) level \\> 2.5 x ULN (Upper limit normal) at screening.\n17. A diagnosis of severe chronic kidney disease, defined as having a glomerular filtration rate (GFR) category 4 or 5 (GFR ≤ 45 mL\u002Fmin\u002F1.73 m2) and albuminuria stage A3 albumin:creatinine ratio (ACR) of \\>300 mg\u002Fg).\n18. Patients with an active malignancy or who have received treatment for any malignancy within 1 year before the screening visit, except for localized basal cell or squamous cell skin cancer that has been cured at least 90 days before screening.\n19. Patients with a history of metastatic malignancy.\n20. Women who are pregnant or lactating.\n21. Patients with a known allergy or hypersensitivity to heparin or heparin products, and\u002For antiplatelet agents (e.g., aspirin or clopidogrel).\n22. Participation in an investigational drug or device study within 30 days prior to screening.\n23. Patients who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they received placebo only).\n24. Patients with known antiphospholipid antibody syndrome or other thrombophilia.\n25. Patients with a medical history of severe infection or vasculitis due to an autoimmune disease, inflammatory bowel disease (IBD) or Crohn's disease.\n26. Any concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject.\n27. Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n28. Patients with anamnestic history of drug abuse (defined as illicit drug use) or anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 12 months.\n\nINCLUSION CRITERIA HEALTHY VOLUNTEERS\n\n1. Male or female volunteers 40-80 years old, inclusive.\n2. Healthy status defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis.\n3. No diagnosis of diabetes, pre-diabetes or insulin resistance.\n4. Normal eGFR as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n5. Premenopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.\n6. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential\n7. Healthy volunteers should be able to understand all study-related information in Dutch.\n\nEXCLUSION CRITERIA HEALTY VOLUNTEERS\n\n1. Any sign or symptom of PAOD\u002FCLI or other cardiovascular disease.\n2. Abnormal ankle-brachial index (ABI) at rest and\u002For decrease of ABI following treadmill exercise.\n3. Use of any anticoagulant or antiplatelet (not including aspirin at recommended doses) agent within the recent 12 months before screening.\n4. Any regular prescription or over-the-counter medication, except for vitamins.\n5. Medical history of heparin-induced thrombocytopenia.\n6. Medical history of atrial fibrillation and\u002For those with a mechanical heart valve.\n7. Major surgery, major trauma or organ biopsy within the past 90 days before screening.\n8. Medical history of, or any condition, associated with an increased bleeding risk.\n9. Arterial hypertension (systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg.\n10. Subjects with a medical history of, or an existing aneurysm.\n11. Hemoglobin \\\u003C8.0 mmol\u002FL (130 g\u002Fl) (men) or \\\u003C7.5 mmol\u002FL (120 g\u002Fl) (women) at screening or platelet count \\< 150 x 109\u002FL or leukocyte count above normal (12 x 109\u002FL).\n12. Clinically significantly prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT) (\\> 1.2-fold).\n13. Participation in an investigational drug or device study within 30 days prior to screening.\n14. Subjects who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they were received placebo only).\n15. Subjects with known thrombophilia.\n16. Women who are pregnant or lactating.\n17. Subjects unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n18. Subjects with anamnestic history of drug abuse (defined as illicit drug use) or a anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 3 months.",true,{"count":255,"type":21},[54],"The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of \\[89Zr\\]Zr-DFO-APAC in patients with peripheral arterial occlusive disease \u002F critical limb ischemia (PAOD\u002FCLI) and healthy volunteers. The main questions it aims to answer are:\n\n* What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of \\[89Zr\\]Zr-DFO-APAC?\n* What is the biodistribution and internal radiation dosimetry of the tracer dose of \\[89Zr\\]Zr-DFO-APAC?\n* What is the binding and retention time of \\[89Zr\\]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the \\[89Zr\\]Zr-DFO-APAC (IMP) and PET\u002FCT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.",[424,27],"Peripheral Arterial Occlusive Disease","2025-01-28",{"date":427,"type":33},"2025-01-30",{"date":429,"type":33},"2024-02-01",{"date":431,"type":21},"2025-06",{"name":433,"class":174},"Aplagon Oy",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":52,"phases":442,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":70},"100577232","phase-1-tolerance-study-of-allogeneic-of-adipose-tissue-derived-mesenchymal-stromastem-cells-admsc-transplantation-in-patients-with-critical-limb-ischemia-100577232","NCT06795620","Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma\u002FStem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.","AlloDREAM","Inclusion Criteria:\n\n* Patients over 18 years old,\n* Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,\n* Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,\n* Patient with a life expectancy greater than 6 months,\n* Patients who signed the informed consent,\n* Women of childbearing age with effective contraception (oral contraception, IUD, dermal implant) and with negative pregnancy test,\n* Patient affiliated to a social security system.\n\nExclusion Criteria:\n\n* Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,\n* Another clinical trial participation (except observational studies),\n* Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,\n* Patient allergic to local anesthetics\n* Immunosuppressive therapy\n* Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,\n* Patient under the protection of justice or under guardianship or curatorship.",{"count":255,"type":21},[443],"PHASE1","Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.",[27],[447,448,449],"Adipose tissue","allogeneic AdMSC","cell therapy","2025-01-23",{"date":425,"type":33},{"date":453,"type":21},"2025-01",{"date":455,"type":21},"2028-01",{"name":457,"class":40},"University Hospital, Toulouse",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":41},"100538879","acceleration-time-assessment-for-prediction-of-critical-limb-ischemia-100538879","NCT06296576","Acceleration Time Assessment for Prediction of Critical Limb Ischemia","ATACLI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb and for whom a measurement of the systolic pressure index at the toe will be performed.\n* Presence of proven arterial disease, asymptomatic or not, defined by the presence of one of the following criteria:\n\n  * Rest ankle systolic pressure index ≤ 0.90\n  * Rest toe systolic pressure index ≤ 0.70\n\nExclusion Criteria:\n\n* Patient with haemodynamic instability, unable to tolerate a delay in therapeutic management caused by the ultrasound examination and measurement of systolic pressure at the toe;\n* Patients with surgical management of the lower limb (in relation to lower limb arteriopathy), already scheduled at the time of inclusion.\n* Patients with a life expectancy of less than 24 hours;\n* History of transmetatarsal amputation or amputation at a more proximal level compromising the measurement of systolic pressure and occlusion at the toe and\u002For TCPO2;\n* Refusal to participate",{"count":466,"type":21},431,"Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries.\n\nIts diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and\u002For necrotic wounds, with a time to onset \\> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \\\u003C 50mmHg or toe systolic pressure (TSP) \\\u003C 30 mmHg or transcutaneous oxygen pressure (TCPO2) \\\u003C 30 mmHg).\n\nRecent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery).\n\nThe main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.",[27],[470,471],"systolic rise time","critical limb ischaemia","2024-08-27",{"date":474,"type":33},"2024-08-29",{"date":476,"type":33},"2024-07-01",{"date":478,"type":21},"2026-09-01",{"name":480,"class":40},"Centre Hospitalier le Mans",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":52,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":70},"100521926","evaluation-of-the-magnitude-bioresorbable-drug-eluting-scaffold-in-the-treatment-of-patients-with-below-the-knee-disease-in-australia-100521926","NCT06075940","Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia","Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold (BRS)in the Treatment of Patients With Below the Knee Disease in Australia","MAGNITUDE-BTK","7.1.1 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 Human Research 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 and ≤ 90 years of age.\n5. Subject agrees to complete all protocol-required follow-up visits, including angiograms.\n\n   7.1.2 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.\n8. Up to two (2) target lesions and two different arteries can be treated, where 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 should 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 residual stenosis by angiography without evidence of distal embolization, thrombus formation, or vessel rupture). Presence of hemodynamically significant lesions (\\>50% stenosis) in the P3 segment of the popliteal artery (infrageniculate) is an exclusion criterion.\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 3.0 - 3.5 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\n7.2 Exclusion Criteria 7.2.1 General 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 involving the target limb. 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    7.2.2 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.\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":51,"type":21},[81],"The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.",[493,27,28],"Critical Limb-Threatening Ischemia","2024-04-08",{"date":496,"type":33},"2024-04-10",{"date":498,"type":33},"2024-03-04",{"date":500,"type":21},"2030-12-31",{"name":502,"class":174},"R3 Vascular Inc.",{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":52,"phases":512,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":70},"100529501","early-phase-1-umbilical-cord-artery-derived-perivascular-stem-cells-for-the-critical-limb-ischemia-therapy-100529501","NCT06174597","Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy","Efficacy and Safety of Umbilical Cord Artery-derived Perivascular Stem Cells in Patients With Critical Limb Ischemia","Inclusion Criteria:\n\n1. Aged between 18 and 80, of any gender;\n2. Diagnosed with lower extremities ischemia, classified as Rutherford Stage IV-V, affecting at least one limb. If both lower limbs have ischemic disease, the researcher will determine which affected limb will be studied. The resting ankle systolic pressure (dorsalis pedis artery or posterior tibial artery) of the affected limb is less than 60mmHg, or the toe systolic pressure is less than 40 mmHg, or the Ankle-Brachial Index (ABI) is less than 0.50;\n3. Within the last month, Digital Subtraction Angiography (DSA), Computed Tomography Arteriography (CTA), Magnetic Resonance Angiography (MRA)，or vascular ultrasound has confirmed that one or more of the arteries (superficial femoral artery, i.e., the femoral artery below the deep femoral artery branch, the popliteal artery, and its following arteries) have a stenosis of ≥75% or occlusion;\n4. Patient experiences rest pain in the limb due to ischemia for at least two weeks;\n5. Inoperable or not suitable for endovascular treatment，or no obvious improvement after surgical treatment;\n6. Expected lifespan \\>2 years;\n7. Good compliance, accepting dietary control and medication treatment, with an informed consent form signed by the patient themselves or their legal representatives.\n\nExclusion Criteria:\n\n1. Acute ischemic disease of the lower limb(s) occurred within the past 2 weeks, or patients with acute progression of lower extremity arterial ischemic disease, or those with local\u002Fdiffuse gangrene;\n2. Unsatisfactory evaluation of condition stability after vascular reconstruction surgery or sympathetic nerve removal surgery performed within 4 weeks，or possibility of undergoing amputation in the next 4 weeks;\n3. Stenosis of ≥75% in the main-iliac artery;\n4. Diabetic patients with HbA1c \\> 10%;\n5. Abnormal laboratory test results that meet any of the following criteria:i. Abnormal blood routine examination: Hemoglobin (HGB)\\\u003C80 g\u002FL, or white blood cell count (WBC)\\\u003C3.0×10\\^9\u002FL, or platelet count (PLT)\\\u003C50×10\\^9\u002FL; ii. Abnormal liver function: Aspartate aminotransferase (AST)\\>2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT)\\>2×ULN, total bilirubin (TBIL)\\>2×ULN; iii. Severe renal dysfunction requiring dialysis treatment;iv. Other abnormal laboratory testing indicators that researchers believe may affect the evaluation of trial results;\n6. Diseases unsuitable for clinical trials, or contraindications to surgery: i. Difficult-to-control hypertension (\\>180\u002F110mmHg), severe heart failure (NYHA IV), or EF\\\u003C30%;ii. Patients who have had a stroke, brain hemorrhage, myocardial infarction, or unstable angina in the past one month; iii. Patients with malignant tumors;iv. Receiving immunosuppressants, hemodialysis, chemotherapy, and radiotherapy; v. Active infection, HIV antibody positive, Hepatitis C antibody positive, Hepatitis B (HBsAg positive and Hepatitis B virus DNA quantitative detection value greater than 1×10\\^3 IU\u002FmL); vi. Serious infections (like cellulitis, osteomyelitis etc.) in the observational limb, exposure of distal fascia or skeleton, unable to maintain wound care for ulcers in the surgical area etc.; vii. History of major surgery or serious injury within the last one months;\n7. During the trial, taking the following drugs at doses greater than stated below, except those who stop medication or adjust the dose to the prescribed dose for 7 days according to the washout period: i. COX-2 inhibitor drugs (such as nimesulide); ii. Aspirin (more than 100 mg\u002Fday);iii. High-dose steroid medications, excluding inhaled steroids; iv. Opioid analgesics (like morphine) for 2 weeks or longer;\n8. Congenital or acquired immunodeficiency;\n9. Pregnant women or those planning pregnancy;\n10. Diseases like pulmonary heart disease and mental illness that researchers believe are unstable and cannot complete the trial, or comorbidities that could interfere with safety checks and effectiveness assessments;\n11. Currently participating in other clinical trials.","80 Years",{"count":110,"type":21},[54],"This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia (CLI). During the second perid, it was a single-center, randomized, controlled prospective study to determine the efficacy of the UCA-PSCs treatment. Those who had CLI were enrolled in the study.",[27],[27,516],"Umbilical cord artery-derived perivascular stem cells","2023-12-07",{"date":519,"type":33},"2023-12-18",{"date":521,"type":33},"2023-06-30",{"date":63,"type":21},{"name":524,"class":40},"Nanjing University",{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":336,"enrollmentInfo":532,"targetDuration":4,"studyType":52,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":70},"100513893","ibs-titan-sirolimus-eluting-iron-bioresorbable-peripheral-scaffold-system-clinical-trial-100513893","NCT05971394","IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial","A Prospective, Multicentre, Single Arm Clinical Trial to Assess the Safety and Effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in Treating Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease","Inclusion Criteria:\n\n• General criteria\n\n1. Subject between 18 and 85 years old.\n2. Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.\n3. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.\n4. Subject requires primary treatment of de novo infrapopliteal lesions.\n\n   • Angiographic criteria\n5. Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.\n6. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.\n7. The target lesion must be located in the proximal 2\u002F3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.\n8. Only two infrapopliteal vessels are allowed to be treated at the same time.\n9. A maximum of two stents can be deployed at one target vessel.\n10. There must be at least one unimpaired artery (\\\u003C 30% stenosis) to the ankle.\n\nExclusion Criteria:\n\n• General criteria：\n\n1. Severe renal insufficiency, hepatic dysfunction (Cr \\> 2 times normal limit or renal dialysis, ALT or AST \\> 5 times normal limit).\n2. Major amputation before index procedure or plan for major amputation.\n3. Any coagulation disorder.\n4. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.\n5. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.\n6. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.\n7. Thromboangiitis obliterans (Buerger's disease).\n8. Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.\n9. Any surgery in target vessel before index procedure.\n10. Volume reduction operation in target vessel before inclusion.\n11. Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.\n12. Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.\n13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.\n14. Women of child-bearing potential not using an effective contraception; pregnant or lactating women.\n15. Subject is not suitable to participate in the trial as per investigators discretion.\n16. Life expectancy ≤ 12 months as per investigators judgement.\n\n    • Angiographic criteria\n17. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis \\>30% with or without intervention.\n18. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has \\> 150 mm stenosis or occlusion before treatment.\n19. Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel.\n20. In-stent restenosis in any lower extremity artery.\n21. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.\n22. Guide wire cannot pass target lesion.\n23. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.\n24. Aneurysm of lower extremity artery in the ipsilateral leg.",{"count":156,"type":21},[81],"The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.",[536,27],"Infrapopliteal Lesions",[538,539,540],"BTK","below-the-knee","Infrapopliteal lesions","2023-07-31",{"date":543,"type":33},"2023-08-02",{"date":545,"type":33},"2023-07-17",{"date":547,"type":21},"2026-07",{"name":549,"class":174},"Biotyx Medical (Shenzhen) Co., Ltd.",{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":557,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":70},"100386493","prospective-cohort-of-patients-with-critical-limb-ischemia-undergoing-revascularization-100386493","NCT04312451","Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization","CLI ENDOVASC","Inclusion Criteria:\n\n* Man or Woman whose age is ≥ 18 years old\n* Patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with hemodynamic criteria (systolic toe pressure \\\u003C30 mm Hg and \u002F or systolic ankle pressure \\\u003C50 mm Hg).\n* Hospitalized in the vascular medicine department\n* Endovascular revascularization gesture discussed and confirmed by multidisciplinary staff\n\nExclusion Criteria:\n\n* Patients under guardianship or curatorship\n* Patients deprived of their liberty\n* Patients objecting to the use of their data for this research",{"count":558,"type":21},300,"Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and \u002F or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.\n\nIn the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.\n\nThe objective of this prospective study is to assess the vital prognosis, limb salvage and associated prognostic factors in patients with critical ischemia supported by endovascular revascularization in the vascular medicine service of the GHPSJ. The objective of this cohort study is to build a database on critical ischemia in hospitalized patients, to judge the management, monitoring and prognosis of patients.",[27],"2022-09-30",{"date":563,"type":33},"2022-10-03",{"date":565,"type":33},"2021-11-05",{"date":567,"type":21},"2027-06-25",{"name":569,"class":40},"Fondation Hôpital Saint-Joseph",{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":70},"100364592","leg-ischaemia-management-collaboration-100364592","NCT04027244","Leg Ischaemia Management Collaboration","LIMb","PRIMARY COHORT\n\nInclusion Criteria:\n\n* All patients presenting to the Leicester Vascular Institute with SLI\n\nExclusion Criteria:\n\n* SLI not caused by PAOD\n* Patients undergoing intervention during their index presentation prior to recruitment\n* Patients lacking capacity to consent with no accompanying next of kin, relative, partner or friend who can act as a personal consulted\n* Patients who cannot read, write or understand English\n* Any significant disease or disorder which may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study\n\nFRAILTY \\& COGNITIVE ADDITIONAL ASSESSMENTS\n\nInclusion criteria:\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI\n* Patients aged ≥65 years\n\nExclusion criteria:\n\n* Nil additional\n\nCARDIAC MRI ADDITIONAL ASSESSMENTS\n\nInclusion criteria:\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention\n\nExclusion criteria:\n\n* Absolute contraindications to cardiac MRI (Pregnancy, Non-MR safe permanent pacemaker, implanted cardiac defibrillator, intra-auricular implant or intra-cranial clips, severe claustrophobia, unstable angina)\n* Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR \\\u003C30mL\u002Fmin\u002F1.73m\\^2))\n* Patients lacking capacity to consent for cardiac MRI\n\nBIOMARKERS ADDITIONAL ASSESSMENTS\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention\n\nExclusion criteria:\n\n* Nil additional","110 Years",{"count":579,"type":21},420,"Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic.\n\nPrimary aim:\n\n\\- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation.\n\nSecondary aims:\n\n* Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation\n* Prevalence and degree of frailty and cognitive impairment\n* Pevalence and degree of cardiac disease (detected by stress MRI)\n* Establish a biobank for future biomarker analysis\n* Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI",[26,27,582,583,584],"Frailty","Cognitive Impairment","Coronary Artery Disease",[586,587,582,588,589,590],"Peripheral arterial disease","Limb salvage","Cognitive dysfunction","Myocardial perfusion imaging","Biomarkers","2020-11-03",{"date":593,"type":33},"2020-11-04",{"date":595,"type":33},"2019-05-10",{"date":597,"type":21},"2031-05-09",{"name":599,"class":40},"University of Leicester"]