[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430508":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Acotec Scientific Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DEB catheter","EXPERIMENTAL","Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm",[13],"Device: DEB catheter",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Trade name of DEB catheter: AcoArt Tulip (0.018\") or AcoArt Litos (0.014\")",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Zhuang Baixi","Xiyuan Hospital of China Academy of Chinese Medical Sciences","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","010-62835122","zhuangbaixi@163.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Chui Yang Liu Hospital affiliated to Tsinghua University","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":19,"email":49},"Yang Yongjiu","010-67700622","docyyj@126.com",{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100430508","acoart-btk-renewa-post-market-clinical-study-100430508",false,"NCT04885985","ACOART BTK RENEW：A Post Market Clinical Study","A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old and ≤75 years old\n* 2\\. Rutherford clinical category classification：3,4 or 5\n* 3\\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.\n* 4\\. Reference vessel diameter is between 2 mm and 4 mm\n* 5\\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.\n\nExclusion Criteria:\n\n* 1\\. Plasma creatinine clearance rate \\\u003C30 mL\u002Fmin\n* 2\\. Acute vessel occlusion or acute thrombosis in target lesion\n* 3\\. Planned amputation on the target limb\n* 4\\. Subjects confined to bed that are completely non-ambulatory.\n* 5\\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.\n* 6\\. Life expectancy \\\u003C 5 year.\n* 7\\. Cumulative length of 100% occluded target lesion(s)\\>150 mm\n* 8\\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm\n* 9\\. History of stroke within 90 days prior to enrollment\n* 10\\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy\n* 11\\. Uncorrectable bleeding diathesis\n* 12\\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery\n* 13\\. Pregnant or breastfeeding female subjects\n* 14\\. Ability to cross a guidewire through target lesion\n* 15\\. Patients who have participated in clinical trials of other medical devices or drugs during the same period","ALL","18 Years","75 Years",{"count":63,"type":64},107,"ESTIMATED","INTERVENTIONAL",[67],"NA","The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.",[70],"Peripheral Artery Disease","2024-07-30",{"date":73,"type":74},"2024-08-01","ACTUAL",{"date":76,"type":74},"2021-12-31",{"date":78,"type":64},"2027-04-01",{"name":5,"class":6},1]