[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654910":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":42,"interventions":49,"overallOfficials":34,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":34,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":34,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":34,"enrollmentInfo":90,"targetDuration":34,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":103,"whyStopped":34,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sakarya University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months","The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.","12 months after the index procedure",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months","The proportion of participants with a patent treated superficial femoral artery segment at each scheduled follow-up, assessed by duplex ultrasonography and defined as a peak systolic velocity ratio of less than 2.4.","1, 3, and 6 months after the index procedure",{"measure":19,"description":20,"timeFrame":21},"Target Lesion Revascularization","The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.","Through 12 months after the index procedure",{"measure":23,"description":24,"timeFrame":25},"Periprocedural Distal Embolization","The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.","Periprocedural",{"measure":27,"description":28,"timeFrame":29},"Macroscopic Material Captured in the Distal Embolic Protection Filter","The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.","Immediately after the index procedure",{"measure":31,"description":32,"timeFrame":33},"Technical Success of the Index Procedure","The proportion of procedures in which the target lesion is successfully crossed and treated with rotational atherectomy and drug-coated balloon angioplasty, with restoration of antegrade flow on final angiography.","At the end of the index procedure",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"NA","SINGLE_GROUP","All participants will receive distal embolic protection, rotational atherectomy, and drug-coated balloon angioplasty.","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection","EXPERIMENTAL","Participants will undergo placement of a distal embolic protection filter followed by rotational atherectomy and drug-coated balloon angioplasty for chronic total occlusion of the superficial femoral artery. Bailout stenting may be performed in cases of flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.",[48],"Device: Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":34},"DEVICE","Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty","After successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery. Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty. Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.",[44],[56],{"name":57,"role":58,"phone":59,"phoneExt":34,"email":60},"ÖMER FARUK TOPALOĞLU, MD","CONTACT","+90 264 888 40 00","ofaruktopaloglu@gmail.com",[62],{"facility":63,"status":34,"city":64,"state":65,"zip":66,"country":67,"countryCode":34,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Sakarya Training and Research Hospital","Adapazarı","Sakarya","54100","Turkey (Türkiye)",{"type":69,"coordinates":70},"Point",[71,72],30.40333,40.78056,{"lat":72,"lon":71},[75],{"name":57,"role":58,"phone":76,"phoneExt":34,"email":60},"+90 264 888 4000",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","ömer faruk topaloglu","Assistant Professor of Radiology","100654910","rotational-atherectomy-and-drug-coated-balloon-angioplasty-with-embolic-protection-for-superficial-femoral-artery-occlusions-100654910",false,"NCT07803718","Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions","Prospective, Single-Center Evaluation of Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Distal Embolic Protection for Chronic Total Occlusions of the Superficial Femoral Artery","Inclusion Criteria:\n\n* Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery\n\nExclusion Criteria:\n\n* Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery","ALL","18 Years",{"count":91,"type":92},60,"ESTIMATED","INTERVENTIONAL",[36],"Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages.\n\nApproximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication.\n\nParticipants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.",[97,98],"Peripheral Artery Disease","Atherectomy in Diseased Lower Extremity Arteries",[100,101,102],"Rotational Atherectomy","Distal Embolic Protection","Endovascular Revascularization","NOT_YET_RECRUITING","2026-09-03",{"date":106,"type":107},"2026-09-04","ACTUAL",{"date":109,"type":92},"2026-09-01",{"date":111,"type":92},"2028-09-01",{"name":5,"class":6},1]