[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505990":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":56,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Atherectomy+Drug-coated balloon","EXPERIMENTAL","The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.",[13],"Device: Atherectomy+Drug-coated balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Drug-coated balloon","ACTIVE_COMPARATOR","The lesion treated by UltrafreeTM drug-coated balloon only.",[19],"Device: Drug-coated balloon",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"drug-coated balloon only in the active comparator group.",[15],[30],{"name":31,"affiliation":32,"role":33},"Meng Ye, M.D.","Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Ni Qihong, M.D.","CONTACT","+8615801900772","niqihong1989@163.com",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Renji Hospital","Shanghai","Shanghai Municipality","200127","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[57,59,61,63,65,67,69,71],{"name":58,"class":6},"Xuanwu Hospital, Beijing",{"name":60,"class":6},"Second Affiliated Hospital of Soochow University",{"name":62,"class":6},"Affiliated Hospital of Nantong University",{"name":64,"class":6},"First Affiliated Hospital of Zhejiang University",{"name":66,"class":6},"Zhejiang University",{"name":68,"class":6},"Qingdao Hiser Medical Group",{"name":70,"class":6},"Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology",{"name":72,"class":6},"Huashan Hospital","100505990","atherectomy-followed-with-a-drug-coated-balloon-in-the-treatment-of-long-femoropopliteal-lesions-100505990",false,"NCT05868564","Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions","Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions","Inclusion Criteria:\n\n1. Subject must be between 18 and 85 years old;\n2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;\n3. Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(\\>70% diameter stenosis) \\>15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;\n4. Patent distal popliteal artery and at least one patent distal runoff;\n5. Willing to comply with the follow-up evaluation;\n6. Written informed consent prior to any study procedures.\n\nExclusion Criteria:\n\n1. Women during pregnancy and lactation, or patients with baby planning;\n2. Life expectancy\\\u003C2 years;\n3. Target lesion\u002Fvessel with in-stent restenosis\n4. Target restenosis\u002Fvessel lesion previously treated with drug coated balloon or atherectomy \\\u003C12 months\n5. Subjects s who are currently participating in other interventional drug or device trials;\n6. Angiographic evidence of thrombus within the target vessel\n7. Subjects have a history of stroke within 3 months;\n8. Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;\n9. Concomitant Renal failure with a serum creatinine\\>2.0mg\u002Fdl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.","ALL","18 Years","85 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.",[91],"Peripheral Arterial Disease",[93,94],"Atherectomy","drug coated balloon","NOT_YET_RECRUITING","2023-05-19",{"date":98,"type":99},"2023-05-22","ACTUAL",{"date":101,"type":85},"2023-07-01",{"date":103,"type":85},"2027-07-31",{"name":5,"class":6},1]