[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-artery-disease-pad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-artery-disease-pad":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,75,101,133,157,185,216,251,281,306],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100617437","phase-3-reducing-adverse-vascular-outcomes-with-factor-xi-inhibition-in-adult-participants-with-peripheral-artery-disease-100617437",false,"NCT07318610","Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease","A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)","ROXI-PALISADE","Key Inclusion Criteria:\n\n1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol\n2. At least 1 of the following enrichment factors for major thrombotic vascular events:\n\n   1. Bypass with prosthetic graft\n   2. Endovascular treatment with stenting\n   3. Target lesion length \\>15 cm\n   4. History of LER or amputation for PAD prior to qualifying LER\n   5. Type 2 diabetes mellitus requiring pharmacologic treatment\n   6. Comorbid symptomatic coronary artery disease as described in the protocol\n   7. Chronic kidney disease as described in the protocol\n   8. Age ≥75 years\n\nKey Exclusion Criteria:\n\n1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome\n2. Has known bleeding diathesis, platelet count \\\u003C50,000\u002Fmm\\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations\n3. Has recent coronary revascularization as described in the protocol\n4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization\n5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period\n6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply","ALL","18 Years",{"count":20,"type":21},7050,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.\n\nThe aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)\n* If the study drugs affect the ability of the blood to clot normally",[27],"Peripheral Artery Disease (PAD)",[29,30],"Blood clots","Lower Extremity Revascularization (LER)","RECRUITING","2026-06-15",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":21},"2026-05-29",{"date":39,"type":21},"2029-11-16",{"name":41,"class":42},"Regeneron Pharmaceuticals","INDUSTRY",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100610331","detecting-peripheral-artery-disease-with-the-pulse-100610331","NCT07226193","Detecting Peripheral Artery Disease With the Pulse","Pulse Arrival Time as an Alternative Biomarker to Detect Lower-Extremity Peripheral Artery Disease","Inclusion Criteria:\n\n1. be able to provide written informed consent\n2. be 19 years of age or older\n3. having or not having a diagnosis of peripheral artery disease\n\nExclusion Criteria:\n\n1. having a current or pervious aortic aneurysm with or without previous intervention\n2. having previous revascularization surgeries (open or endovascular) of the legs or aorta\n3. having walking impairments independent of lower-limb ischemia (e.g., musculoskeletal injury)\n4. having gangrene or ulcers of the toes\u002Ffeet\n5. being currently pregnant or breastfeeding",true,"19 Years",{"count":54,"type":21},60,[56],"NA","1\\) The purpose of this study is to assess segmental pulse arrival time (PAT) as an alternative biomarker to detect lower-extremity peripheral artery disease (PAD), and to investigate the impacts of local skin heating and foot elevation. The secondary purpose will be to investigate the impacts of age on segmental PAT. The subject population will include any adults 19 years of age or older with or without PAD. Exclusion criteria include having an aortic aneurysm with or without previous intervention, previous revascularization surgeries of the arteries in the legs\u002Faorta, walking impairments independent of PAD, gangrene or ulcers of the toes\u002Ffeet, and currently pregnant or breastfeeding. 3) All aims of the present study will be completed with a single laboratory visit. Descriptive measurements will include height, weight, age, sex, body fat percentage, and self-reported medication and health history. Subjects will lie in the supine position for 20-min. After rest, either the ankle-brachial index (ABI) or PAT will be assessed. After 10-min of further rest, the other measurement will be performed. ABIs will be assessed according to current guidelines: blood pressures will be assessed in the dorsal pedis and tibialis posterior arteries of both legs and the brachial arteries of both arms using a blood pressure cuff and Doppler ultrasound. PAT will be simultaneously assessed in both arms and legs using an investigational device with a 3-lead electrocardiogram sensor and four photoplethysmography (PPG) sensors. A PPG sensor will be applied to a finger on each hand and both big toes. Signals will be collected for 15-min with finger and toe sensor temperatures at 30 C. Toe sensor temperature will then be elevated to 45 C for 15-min. Finally, toe sensor temperature will remain at 45 C, and the feet will be elevated 8-in with a soft cushion for 15-min. Blood pressure in the arm and legs will be assessed at the end of each stage. Thermal images of the fingers and toes will be assessed before using the investigational device and after each stage. Subjects will then participate in a 6-min walking test (6MWT) to objectively establish walking capacity. The 6MWT will be performed in accordance with current guidelines. Segmental PATs will be compared with ABI and 6-min walking time to determine if segmental PATs can predict lower-extremity PAD (ABI) and the associated walking impairment (6MWT). This study is expected to last \\~2.5hrs. 4) There will be no follow-up.",[27],[60,61,62,63],"pulse arrival time","atherosclerosis","peripheral artery disease","portable peripheral artery disease detection","2026-05-14",{"date":66,"type":35},"2026-05-19",{"date":68,"type":35},"2026-02-05",{"date":70,"type":21},"2027-01-01",{"name":72,"class":73},"University of Nebraska","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100568927","serranator-point-force-registry-100568927","NCT06687590","Serranator POINT FORCE Registry","POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter","POINT FORCE","Inclusion Criteria:\n\n* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.\n* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.\n* Age of subject is \\> 18.\n* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.\n* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.",{"count":84,"type":21},500,"1 Day","OBSERVATIONAL","The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.\n\nThe data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.",[27,89,90],"Dysfunctional AV Fistula","Dysfunctional AV Graft","2026-05-01",{"date":93,"type":35},"2026-05-07",{"date":95,"type":35},"2025-01-22",{"date":97,"type":21},"2026-08-31",{"name":99,"class":42},"Cagent Vascular LLC",19,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100629162","chocolate-balloon-vs-standard-balloon-angioplasty-before-drug-coated-balloon-treatment-for-femoropopliteal-artery-narrowing-or-blockage-100629162","NCT07471087","Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage","Multicenter Randomized Controlled Trial Comparing Chocolate Percutaneous Transluminal Angioplasty Balloon Versus Plain Old Balloon Angioplasty for Vessel Preparation Prior to Drug-Coated Balloon Treatment in Patients With Femoropopliteal Stenotic or Occlusive Lesions.","CHOICE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for endovascular revascularization of the femoropopliteal artery\n* Rutherford Category 3, 4, or 5\n* De novo femoropopliteal lesion\n* Stenosis ≥ 70% or chronic total occlusion (CTO)\n* Any degree of calcification\n* Any lesion length\n* At least one patent infrapopliteal vessel to the foot\n* Expected life expectancy \\> 12 months\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* No indication for endovascular revascularization of the femoropopliteal artery\n* Rutherford Category 0, 1, 2, or 6\n* Restenotic lesion\n* Absence of at least one patent infrapopliteal vessel to the foot\n* Inability to complete the planned follow-up\n* Life expectancy \\\u003C 12 months\n* Pregnancy",{"count":110,"type":21},242,[56],"The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with femoropopliteal artery narrowing or blockage. It will also learn about the safety of the Chocolate PTA balloon. The main questions it aims to answer are:\n\nDoes using the Chocolate PTA balloon reduce the need for bailout stenting or vessel complications during DCB treatment?\n\nWhat medical problems do participants have when receiving the Chocolate PTA balloon compared with standard balloon angioplasty?\n\nResearchers will compare the Chocolate PTA balloon to standard plain old balloon angioplasty (POBA) to see if it improves vessel preparation before DCB therapy.\n\nParticipants will:\n\nUndergo lesion preparation with either the Chocolate PTA balloon or standard balloon angioplasty, followed by DCB treatment\n\nHave clinical and imaging follow-up visits to assess safety and vessel patency\n\nReport any complications or adverse events throughout the study",[27,114,115,116],"Femoropopliteal Artery Disease","Vascular Lesion Preparation","Critical Limb-Threatening Ischemia",[118,119,120,121,122],"Peripheral Artery Disease","Femoropopliteal Lesions","Drug-Coated Balloon","Balloon Angioplasty","vessel preparation","NOT_YET_RECRUITING","2026-03-11",{"date":126,"type":35},"2026-03-13",{"date":128,"type":21},"2026-06",{"date":130,"type":21},"2029-06",{"name":132,"class":73},"Felice Pecoraro",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":74},"100605939","validity-and-reliability-of-the-6-minute-stepper-test-in-patients-with-peripheral-artery-disease-100605939","NCT07169045","Validity and Reliability of the 6-minute Stepper Test in Patients With Peripheral Artery Disease","Examination of the Validity and Reliability of 6-minute Stepper Test in Patients With Peripheral Artery Disease","Inclusion Criteria:\n\n* Diagnosed with peripheral artery disease by the Department of Cardiovascular Surgery,\n* Ankle-brachial index (ABI) ≤1.40 or exercise ABI ≤0.73 or diagnosed with calcified vascular response, in remission and under follow-up,\n* Stable,\n* Ages between 18 and 80,\n* Patients who volunteer to participate in the study will be included.\n\nExclusion Criteria:\n\n* Patients will be excluded if they have:\n* Previously underwent ischaemic amputation,\n* Unstable coronary artery disease,\n* Uncontrolled Diabetes Mellitus,\n* Pulmonary disease,\n* Acute infection,\n* Weight \\>110 kg because it is the upper limit of the stepper device,\n* Contraindications to exercise testing per the American Sports Medicine Association,\n* Pregnant and breastfeeding women,\n* Patients with PAD who have undergone major surgery or had a myocardial infarction within the last 3 months.","80 Years",{"count":142,"type":21},24,"Hemodynamic dysfunction and decreased blood flow to the extremities negatively affect patients' muscle oxygenation, balance, claudication pain, lower extremity muscle strength, and arterial stiffness. These negatively affect patients' exercise capacity. The six-minute stepper test (6 MST) is a simple, low-cost, and minimal space requirement assessment method used to evaluate functional exercise capacity and is known to be valid and reliable for various pulmonary and cardiovascular diseases. However, it is not known whether the 6 MST is valid and reliable in assessing functional exercise capacity in patients with PAD. It is known that muscle oxygen levels, balance levels, intermittent claudication, lower extremity muscle strength, and arterial stiffness have negative effects on exercise capacity. However, the extent to which these variables affect the 6 MST is unknown. The primary aim is to examine the validity and reliability of the 6 MST in patients with PAD. The secondary aim is to evaluate arterial stiffness, muscle oxygen levels, intermittent claudication, static and dynamic balance levels, lower extremity muscle strength, and examine their effects on the 6 MST.",[27],[118,146,147],"Exercise Testing","Validity and Reliability","2026-01-31",{"date":150,"type":35},"2026-02-03",{"date":152,"type":35},"2025-09-24",{"date":154,"type":21},"2026-07-24",{"name":156,"class":73},"Gazi University",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":166,"studyType":86,"phases":4,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100617037","using-near-infrared-light-to-better-understand-peripheral-artery-disease-100617037","NCT07313410","Using Near-Infrared Light to Better Understand Peripheral Artery Disease","Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease","Inclusion Criteria:\n\n* Cases, Aim 1\n\n  1. 18 or older\n  2. willing to participate under the conditions described in the informed consent form (ICF)\n  3. eligible to sign the ICF\n  4. established diagnosis of PAD confirmed by a physician\n  5. able to comply with the study requirements\n* Cases, Aim 2\n\n  1\\) completed Aim 1\n* Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease\n\nExclusion Criteria:\n\n* Cases, Aim 1\n\n  1. Ankle-Brachial Index \\>0.9 or \\\u003C0.4\n  2. isolated disease in aorta\u002Filiac vessels\n  3. unstable angina or myocardial infarction in past 12 months\n  4. orthopedic or other physical limitations which would prevent data collection\n  5. contraindications to MRI, including presence of a Pacemaker, presence of bone growth\u002F bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator\n* Cases, Aim 2\n\n  1. unstable angina or myocardial infarction in past 12 months\n  2. orthopedic or other physical limitations which would prevent data collection\n  3. contraindications to MRI, including presence of a pacemaker, presence of bone growth\u002F bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).\n* Controls 1) history of peripheral artery disease 2) overt cardiovascular disease (e.g. heart failure) 3) known pulmonary disease (excluding mild asthma) 4) current tobacco use 5) orthopedic or other physical limitations which would prevent data collection, 6) BP \\>150\u002F90 mmHg at screening 7) contraindications to MRI, including presence of a pacemaker, presence of bone growth\u002F bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).",{"count":165,"type":21},120,"6 Months","The goal of this study is to better understand how blood flows and how oxygen is utilized in the lower limbs of people who suffer from peripheral artery disease. This study will also assess how these factors affect treatment outcomes.\n\nSpecific aims include:\n\nAim 1: Utilize BB-NIR-DCS to differentiate PAD patients experiencing primary oxygen delivery limitations from those suffering from mitochondrial dysfunction.\n\nAim 2: Test the efficacy of BB-NIR-DCS at predicting individual responses to vascular intervention.",[27],[170,171,172,173,174,118],"Exercise MRI","Functional Performance","Ankle-Brachial Index","Questionnaires","MRI","2025-12-16",{"date":177,"type":35},"2026-01-02",{"date":179,"type":35},"2025-11-01",{"date":181,"type":21},"2028-12-31",{"name":183,"class":73},"The University of Texas at Arlington",2,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100609017","a-study-to-evaluate-the-safety-and-effectiveness-of-the-fastwave-artero-peripheral-intravascular-lithotripsy-ivl-system-in-adults-with-peripheral-artery-disease-pad-100609017","NCT07209085","A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)","SPARC: A Prospective, Multicenter Evaluation of the Safety and Performance of the Artero Intravascular Lithotripsy System for the Treatment of Peripheral Artery Disease and Remodeling Arterial Calcium","SPARC","Inclusion Criteria\n\n1. Subject is able and willing to comply with all assessments in the study.\n2. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.\n3. Subject is ≥ 18 years of age.\n4. Rutherford Clinical Category 2, 3 or 4\n5. Resting ABI of ≤0.90, or ≤0.75 after exercise, of the target leg.\n6. Lesion calcification is moderate or severe using the PARC3calcium classification definition, or by intravascular ultrasound (IVUS) determined by the investigator.\n\n   1. Moderate is defined as ≥ 180º to 270º and \\\u003C 50% of the total lesion length.\n   2. Severe is defined as \\>270º and \\> than 50% of the total lesion length.\n7. Estimated life expectancy \\>1 year, in the opinion of the investigator at the time of enrollment.\n8. Target lesion that is in a native de novo femoral-popliteal arteries. Non-target lesions can be in the iliac arteries (inflow).\n9. The subject is a suitable candidate for angiography and endovascular intervention, in the investigator's opinion or per the hospital guidelines.\n10. In the opinion of the investigator by visual estimate, the target lesion is ≥70% stenosis or is occluded.\n11. According to the visual estimate, the target lesion reference vessel diameter is between 3.5mm and 8.0mm.\n12. The total planned target lesion length must be ≤220 mm.\n\n    1. Tandem lesions (i.e., two or more lesions in close proximity) may be considered a single lesion if the distance between them is ≤ 30 mm.\n    2. Multiple target vessel beds and discrete (non-contiguous) lesions may be treated, provided the combined total length of all treated lesions does not exceed 220 mm.\n13. Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis \\>50% distal to the target lesion.\n\n    a. If the peroneal artery, at least one collateral must supply the foot.\n14. Retrograde access is permitted for lesion crossing; however, the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System must be deployed from antegrade (either ipsilateral or contralateral) access.\n\nExclusion Criteria\n\n1. Planned use of atherectomy, scoring or cutting balloons, or any investigational device other than lithotripsy.\n2. Rutherford Clinical Categories 0, 1, 5, and 6.\n3. The investigator determined no or mild calcium in the target lesion.\n4. Subject has outflow disease in which no tibial vessel has \\\u003C50% stenosis. Staged or concomitant intervention to the tibial vessels is not allowed.\n5. The subject has significant inflow disease, defined as \\>50% stenosis or occlusion in the inflow tract proximal to the target lesion, that has not been successfully treated prior to treatment of the superficial femoral artery (SFA) or popliteal lesion.\n\n   a. Successful treatment is defined as residual stenosis ≤30% without a flow-limiting dissection or vessel perforation.\n6. The subject has significant outflow disease in which no tibial vessel has \\\u003C50% stenosis. Staged or concomitant intervention to the tibial vessel is not allowed.\n7. Inability to pass the guidewire across the target lesion.\n8. In-stent restenosis within the lesion(s) to be treated.\n9. Lesions within autologous or synthetic vessel grafts.\n10. Evidence of aneurysm or thrombus in the vessels to be treated.\n11. History of prior endovascular or surgical intervention on the index limb within 14 days prior to the index procedure, unless part of a pre-specified, staged treatment plan.\n12. Intervention on the contralateral limb is required within the next 14 days.\n13. History of thrombolytic therapy within two weeks of enrollment.\n14. Subject has a known hypercoagulable state, coagulopathy, or has a bleeding diathesis, thrombocytopenia with platelet counts less than 100,000\u002Fmicroliter, or International Normalized Ratio (INR) \\>1.5.\n15. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.\n16. Myocardial infarction within 60 days prior to enrollment.\n17. History of stroke within 60 days prior to enrollment.\n18. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.\n19. Subject has acute or chronic renal disease defined as serum creatinine of \\>2.5 mg\u002FdL or \\>220 µmol\u002FL, or on dialysis.\n20. Subject has an active infection requiring antibiotic therapy.\n21. Subject has known allergy to contrast agents, medications, or catheter materials used to perform endovascular intervention that cannot be adequately pre-treated.\n22. Subject is pregnant or nursing.\n23. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.\n24. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.",{"count":194,"type":21},110,[56],"The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled blockages in their leg arteries.\n\nThe study will test the idea that using sound waves inside the artery can safely break up calcium and make it easier to open the artery so blood can flow better.\n\nThe main question this study is trying to answer is:\n\nCan treatment with the FastWave Artero™ IVL System safely widen blocked leg arteries and lower the chance of serious problems during or after the procedure?\n\nAbout 110 adults at up to 30 medical centers in the United States will take part. Everyone in the study will receive the IVL treatment.\n\nDuring the study, participants will:\n\nHave a minimally invasive procedure using the FastWave IVL System\n\nStay for a short observation period after the procedure\n\nReturn for follow-up visits about 30 days and 6 months later\n\nResearchers will look at how well the arteries open, how long they stay open, and whether any major complications occur. The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.",[27],[27,199,200,201,202,203,204,205,206],"Lower Extremity Arterial Disease","Femoropopliteal Artery","Arterial Calcification","Vascular Calcification","Endovascular Therapy","Intravascular Lithotripsy (IVL)","FastWave Artero IVL System","Angioplasty","2025-10-07",{"date":209,"type":35},"2025-10-09",{"date":211,"type":21},"2025-12",{"date":213,"type":21},"2027-03",{"name":215,"class":42},"FastWave Medical",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":236,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":74},"100606246","algae-effects-in-markers-of-cardiovascular-risk-and-gut-microbiome-100606246","NCT07173062","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial","CALGUT","Inclusion Criteria:\n\n* ≥50 years\n* BMI ≥20 kg\u002Fm2\n* History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR \\\u003C75 ml\u002Fmin at least for 3 months), albuminuria \\>300 mg\u002Fg, or diabetes mellitus\n* No antibiotics in the previous 30 days\n* If a woman, she must be a woman of non-childbearing potential. That is, she must be:\n\n  * Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy);\n  * Clinically diagnosed infertile;\n  * In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.\n* A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:\n\n  * Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);\n  * Intrauterine device;\n  * Intrauterine hormone-releasing system;\n  * Bilateral tubal occlusion;\n  * Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.\n\nExclusion Criteria:\n\n* Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign\u002Fcomplete the informed consent form on the patient's behalf).\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Participation in another clinical study with an investigational product during the last month.\n* In participants recruited at Unidade Local de Saúde de São João, the exclusion criteria applied is estimated Glomerular Filtration Rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1.73m2 estimated with the CKD-EPI (2021) formula or dialysis. For participants recruited at community, this exclusion criteria is adapted for diagnosis of end-stage renal disease or dialysis (no need to quantify the eGFR).","50 Years",{"count":226,"type":21},150,[56],"The Western diet, rich in fat and sugar, contributes to cardiovascular risk and alters the body metabolism, specifically through the modulation of the microbiome. Microbiome is considered the \"second genome\", functioning as an endocrine-like organ. Gut microbiota-derived metabolites, namely trimethylamine- N-oxide and short-chain fatty acids have been associated with atherosclerosis, vascular and cardiac diseases. Regarding trimethylamine- N-oxide, its association with cardiovascular disease is positive and dose-dependent. In contrast, short-chain fatty acids have been positively associated with the improvement of cardiovascular health.\n\nAlgae probiotics can modulate gut microbiome, stimulating the growth of commensal micro-organisms with health benefits. Previous studies suggested that Spirulina Arthrospira platensis supplementation could improve blood lipid levels and lower blood pressure, revealing anti-inflammatory and antioxidant roles. Other probiotics that could be beneficial to gut microbiota are macroalgae or seaweed. Macroalgae are a rich source of components which may prompt bacterial diversity and abundance.\n\nThe present prospective, randomized, three-armed parallel trial aims to generate good-quality evidence about the potential health effects and impact of Spirulina Arthrospira platensis (microalgae) and Gelidium corneum (macroalgae) supplements in humans. These participants will undergo 3 clinical evaluations: 2 before the beginning of micro- and macro-algae supplementation and the last one after 20 weeks of supplementation. The evaluation includes a vascular, nutritional and physical activity assessment, as well as blood, urine, saliva and stool collection for quantification of plasma biomarkers, oral and gut microbiota analysis, respectively.",[230,231,232,233,27,234,235],"Stroke","Coronary Arterial Disease (CAD)","Myocardial Infarction (MI)","Diabetes Mellitus","Chronic Kidney Disease(CKD)","Albuminuria",[237,238,239,240,241],"Spirulina Arthrospira platensis","Gelidium corneum","Trimethylamine- N-oxide (TMAO)","Short-Chain Fatty Acids (SCFA)","Cardiovascular risk (CVR)","2025-09-12",{"date":244,"type":35},"2025-09-15",{"date":246,"type":35},"2025-03-11",{"date":248,"type":21},"2026-08",{"name":250,"class":73},"Universidade do Porto",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100563830","exercise-activity-to-improve-mobility-in-patients-with-ckd-and-pad-100563830","NCT06621264","Exercise Activity to Improve Mobility in Patients With CKD and PAD","EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial","EXACT-CKDPAD","Inclusion Criteria:\n\n* chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III;\n* ability to walk independently;\n* cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20\u002F30\n* absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g\u002Fdl).\n\nExclusion Criteria:\n\n* major amputations;\n* major surgery planned in the next 3 months;\n* known comorbid conditions that may limit survival to less than 2 years;\n* inability or unwillingness to comply with protocol requirements.",{"count":260,"type":21},124,[56],"People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study.\n\nWhose providing informed consent, will be randomly assigned to one of two groups:\n\n1. Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.\n2. Control group: receiving usual care including optimal medical therapy and nutritional advice.\n\nPatients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.",[264,27],"Chronic Kidney Disease Stage 3 and 4",[266,267,268,269,270],"Exercise therapy;","Mobility","Ageing","Chronic Kidney Disease","Peripheral artery disease","2025-05-30",{"date":273,"type":35},"2025-05-31",{"date":275,"type":35},"2024-10-01",{"date":277,"type":21},"2026-12-31",{"name":279,"class":73},"University Hospital of Ferrara",3,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":74},"100562595","safety-and-effectiveness-of-the-peripheral-balloon-expandable-covered-stent-system-for-iliac-artery-stenosisocclusion-select-100562595","NCT06605209","Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis\u002FOcclusion. (SELECT)","A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and\u002For Occlusive Lesions in the Common and External Iliac Arteries.","SELECT","Inclusion Criteria:\n\n* Participants aged 18 to 80 years, regardless of sex;\n* Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;\n* Participants with a Rutherford classification of 2 to 4 for the target limb;\n* Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant, or breastfeeding women;\n* Participants who have previously had a vascular graft implanted in the native iliac artery;\n* Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;\n* Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \\< 80×10\\^9\u002FL);\n* Participants with serum creatinine ≥ 221 μmol\u002FL (2.5 mg\u002FdL) or currently undergoing dialysis;\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;\n* Severe anemia (hemoglobin level \\< 60.0 g\u002FL);\n* Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;\n* Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;\n* Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;\n* Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;\n* Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;\n* Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.",{"count":290,"type":21},130,[56],"This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and\u002For occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.",[27],[295,296],"Covered Stent","iliac artery","2024-11-29",{"date":299,"type":35},"2024-12-04",{"date":301,"type":35},"2024-11-08",{"date":303,"type":21},"2026-12-15",{"name":305,"class":42},"Zhejiang Zylox Medical Device Co., Ltd.",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":74},"100570946","angioplasty-with-shockwave-ivl-catheter-system-in-femoropopliteal-lesions-100570946","NCT06713850","Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions","Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries","SHIELD","Inclusion Criteria:\n\n\\-\n\n1\\) Age ≥ 18 years (2) Rutherford Classification 2-5 3) Stenosis (\\>70% stenosis confirmed by digital subtraction angiography (DSA) imaging) or occlusion of the femoropopliteal artery, with one healthy patent outflow tract distal to the knee in continuity with a patent outflow tract below the ankle.\n\n(4) Patients who understand the purpose of the study, participate in the experiment voluntarily, sign the informed consent form and are willing to be followed up.\n\n5\\) The guidewire needs to pass through the lesion; 6) Life expectancy \\>24 months 7) Moderately severe calcified lesions confirmed by imaging data: 8) For patients who receive intervention in both lower extremities may be enrolled in order of time of intracavitary treatment 9) For combined aortoiliac artery lesions that have undergone endoluminal revascularization to achieve flow recanalization without more than 50% residual stenosis.\n\nExclusion Criteria:\n\n1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment (2) Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.\n\n3\\) Patients who have been enrolled in medications that interfere with this clinical trial within the last 3 months or who have been treated intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, and so on; 4) Pregnant and lactating women 5) Patients who are unable or unwilling to participate in this trial. 6) patients with Berger's disease 7) patients who have received arterial bypass diversion on the treated side",{"count":290,"type":21},"There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.",[27,317],"Chronic Limb Threatening Ischemia",[118,317,319],"Severe calcification","2024-11-27",{"date":322,"type":35},"2024-12-03",{"date":324,"type":21},"2024-12-01",{"date":326,"type":21},"2028-11",{"name":328,"class":73},"Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology"]