[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437906":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":43,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":43,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":43,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":85,"whyStopped":43,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Acotec Scientific Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus-eluting balloon angioplasty","EXPERIMENTAL","Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and\u002For popliteal artery",[13],"Device: Sirolimus-eluting balloon catheter",{"label":15,"type":16,"description":17,"interventionNames":18},"Paclitaxel-eluting balloon angioplasty","ACTIVE_COMPARATOR","Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and\u002For popliteal artery",[19],"Device: Paclitaxel-eluting balloon catheter",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Sirolimus-eluting balloon catheter","Sirolimus-eluting balloon catheter designed and produced by Acotec",[9],[27],"Sirolimus coated balloon catheter",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Paclitaxel-eluting balloon catheter","Paclitaxel-eluting balloon catheter (trade name:DHALIA)",[15],[33],"Paclitaxel coated balloon catheter",[35],{"name":36,"affiliation":37,"role":38},"Guo Wei, MD","Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","010-66887329",null,"pla301dml@vip.sina.com",[46],{"facility":37,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Beijing","Beijing Municipality","100039","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":42,"phoneExt":43,"email":44},"Wei Guo, MD",{"type":63,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100437906","acoart-scb-sfa-sirolimus-coated-balloon-catheter-in-the-treatment-of-femoropopliteal-artery-stenosis-100437906",false,"NCT04982367","Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis","A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.","Inclusion Criteria:\n\n* Age ≥18 years old and ≤80 years old\n* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5\n* SFA and\u002For popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.\n* The length of target lesion less than 20 cm\n* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed\n\nExclusion Criteria:\n\n* The plasma creatinine level is higher than 150 umol\u002FL\n* Thrombolysis or thrombectomy is required\n* There are more than 2 lesion need to treat in the target vessel.\n* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.\n* The target lesion had residual stenosis\\>30% or flow-limit dissection after pre-dilatation.\n* The patient had outflow less than 1 vessel\n* The lesion located in a stent.\n* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.\n* Women who are pregnant or breast-feeding.\n* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.\n* Patient has life expectancy of less than 12 months.\n* The investigator think the patient is not suitable for participation in the clinical trial.","ALL","18 Years","80 Years",{"count":75,"type":76},166,"ESTIMATED","INTERVENTIONAL",[79],"NA","A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis",[82],"Peripheral Artery Disease",[84,82],"Drug eluting balloon catheter","UNKNOWN","2023-10-16",{"date":88,"type":89},"2023-10-18","ACTUAL",{"date":91,"type":89},"2021-12-08",{"date":93,"type":76},"2024-07",{"name":5,"class":6},1]