[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607328":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":16,"studyPopulation":16,"armGroups":39,"interventions":45,"overallOfficials":16,"centralContacts":16,"locations":51,"responsibleParty":84,"collaborators":16,"id":86,"slug":16,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":16,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":16,"studyType":97,"phases":98,"briefSummary":99,"conditions":100,"keywords":16,"overallStatus":102,"whyStopped":16,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"BrosMed Medical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Patency Rate at 12 months post-procedure","12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis).\n\nClinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis.\n\nTarget Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.","12 months",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Device Success Rate",null,"Immediately after procedure",{"measure":19,"description":16,"timeFrame":20},"Primary Patency Rate at 24 months post-procedure","24 months",{"measure":22,"description":16,"timeFrame":23},"Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure","12 months; 24 months",{"measure":25,"description":16,"timeFrame":26},"Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively","6, 12, 24 months",{"measure":28,"description":16,"timeFrame":29},"Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively","12, 24 months",{"measure":31,"description":32,"timeFrame":29},"MAEs Rates at 12 Months and 24 Months Post-Procedure","MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR).",{"allocation":34,"interventionModel":35,"interventionModelDescription":16,"primaryPurpose":36,"observationalModel":16,"timePerspective":16,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":16,"whoMasked":16},"NONE",[40],{"label":41,"type":42,"description":16,"interventionNames":43},"VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter","EXPERIMENTAL",[44],"Device: drug coating balloon angioplasty",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":16},"DEVICE","drug coating balloon angioplasty","The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions",[41],[52,70],{"facility":53,"status":16,"city":54,"state":55,"zip":16,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Xuanwu Hospital Capital Medical University","Beijing","Beijing Municipality","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":16,"email":69},"Lianrui Guo","CONTACT","010-83199270","Guolianrui@xwhosp.org",{"facility":71,"status":16,"city":72,"state":73,"zip":16,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chognqing",{"type":59,"coordinates":75},[76,77],106.55771,29.56026,{"lat":77,"lon":76},[80],{"name":81,"role":67,"phone":82,"phoneExt":16,"email":83},"Fenghe Li","023-89011876","Lifenghe@163.com",{"type":85,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100607328",false,"NCT07187128","A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.","Inclusion Criteria:\n\n1. Aged 18 to 85 years, gender not restricted;\n2. Rutherford grade 2 to 5\n3. Target lesions located in the superficial femoral artery (SFA) and\u002For proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:\n\n   * Diameter stenosis ≥70% by visual estimation or\n   * Chronic total occlusion (CTO)\n4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;\n5. The guidewire can successfully pass through the target lesion site within the vascular lumen;\n6. Agree to participate in this clinical study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment\n2. Type D or higher dissection occurring after target lesion predilation;\n3. Residual diameter stenosis \\>50% following target lesion predilation;\n4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;\n5. Abnormal function of vital organs (liver\u002Fkidney\u002Fbrain) deemed unsuitable for intervention by investigators;\n6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel\u002Fstructural analogs, or contrast agents;\n7. Patients currently undergoing dialysis or immunosuppressive therapy;\n8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;\n9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;\n10. Pregnancy or lactation women;\n11. Currently participation in other drug\u002Fmedical device clinical trials without completion;\n12. Patients deemed by the investigator to be unsuitable for participation in this study.","ALL","18 Years","85 Years",{"count":95,"type":96},150,"ESTIMATED","INTERVENTIONAL",[34],"T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.",[101],"Femoropopliteal Artery Stenoses or Occlusive Lesions","NOT_YET_RECRUITING","2025-09-15",{"date":105,"type":106},"2025-09-22","ACTUAL",{"date":105,"type":96},{"date":109,"type":96},"2028-12-30",{"name":5,"class":6},2]