[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoropopliteal-artery-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoropopliteal-artery-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100629162","chocolate-balloon-vs-standard-balloon-angioplasty-before-drug-coated-balloon-treatment-for-femoropopliteal-artery-narrowing-or-blockage-100629162",false,"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","ALL","18 Years",{"count":20,"type":21},242,"ESTIMATED","INTERVENTIONAL",[24],"NA","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",[27,28,29,30],"Peripheral Artery Disease (PAD)","Femoropopliteal Artery Disease","Vascular Lesion Preparation","Critical Limb-Threatening Ischemia",[32,33,34,35,36],"Peripheral Artery Disease","Femoropopliteal Lesions","Drug-Coated Balloon","Balloon Angioplasty","vessel preparation","NOT_YET_RECRUITING","2026-03-11",{"date":40,"type":41},"2026-03-13","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2029-06",{"name":47,"class":48},"Felice Pecoraro","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100625633","safety-and-effectiveness-of-genoss-pcb-in-patients-with-long-femoropopliteal-lesion-100625633","NCT07425171","Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion","Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)","\\\u003CInclusion criteria\\>\n\nEnrollment in the study was limited to patients who met the following inclusion criteria:\n\n1. Subject was ≥19 years of age.\n2. Subject had target limb Rutherford classification 2, 3, 4 or 5.\n3. Subjects with a stenosis of 70% or greater in the femoropopliteal artery.\n4. Subjects with a stenotic or occlusive lesion measuring ≥150 mm in total length. (Multiple adjacent lesions separated by less than 3 cm from angiographically healthy segments are treated as a single lesion.)\n5. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.\n6. Subject provided written informed consent and was willing to comply with the study follow-up requirements.\n\n\\\u003CExclusion criteria\\>\n\nPatients were not permitted to enroll in the study if they met any of the following exclusion criteria:\n\n1. Subjects was allergic to paclitaxel.\n2. Subjects with contraindications or hypersensitivity to antiplatelet therapy.\n3. Subject had life expectancy of less than 2 years.\n4. Those who have undergone vascular surgery on the target lesion within the past 6 weeks.\n5. Those who have in-stent restenosis (ISR) on the target lesion.\n6. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.\n7. Women who were pregnant, breast-feeding or intended to become pregnant.\n8. Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.\n9. Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.\n10. Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.","19 Years","85 Years",{"count":59,"type":21},300,"OBSERVATIONAL","The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.",[63,28,64],"PTA (Percutaneous Transluminal Angioplasty)","Long Femoropopliteal Artery Disease","2026-02-13",{"date":67,"type":41},"2026-02-20",{"date":69,"type":21},"2026-02-24",{"date":71,"type":21},"2028-12-31",{"name":73,"class":74},"Genoss Co., Ltd.","INDUSTRY",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":75},"100462867","combination-therapy-of-atherectomy-plus-drug-coated-balloon-versus-drug-coated-balloon-for-complex-femoropopliteal-artery-disease-100462867","NCT05307263","Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease","Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)","ARTEMIS","Inclusion Criteria:\n\n1. Age 19 years or older\n2. Symptomatic peripheral artery disease:\n\n   * Moderate or severe claudication (Rutherford category 2 or 3)\n   * Critical limb ischemia (Rutherford category 4 or 5)\n3. Femoropopliteal artery disease (stenosis \\> 50%) with one of following complex lesion characteristics: - long lesion (\\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)\n4. Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone\n5. Patients with signed informed consent\n\nExclusion Criteria:\n\n1. Acute critical limb ischemia\n2. Severe critical limb ischemia (Rutherford category 6)\n3. Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions\n4. Age \\> 85 years\n5. Severe hepatic dysfunction (\\> 3 times normal reference values)\n6. Significant thrombocytopenia, anemia, or known bleeding diathesis\n7. LVEF \\\u003C 35% or clinically overt congestive heart failure\n8. Pregnant women or women with potential childbearing\n9. Life expectancy \\\u003C1 year due to comorbidity\n10. Previous bypass surgery in the target femoropopliteal artery\n11. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)",{"count":59,"type":21},[24],"* Prospective, multi-center, randomized, controlled comparison study\n* A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.\n* Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.\n* Patients will be followed clinically for 2 years after the procedure.",[28],[89,90,91,92],"Femoropopliteal artery disease","drug-coated balloon","angioplasty","atherectomy","RECRUITING","2025-05-02",{"date":96,"type":41},"2025-05-04",{"date":98,"type":41},"2022-09-15",{"date":100,"type":21},"2029-12",{"name":102,"class":48},"Yonsei University"]