[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Felice Pecoraro\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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",""]