[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430508":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":48,"interventions":55,"overallOfficials":60,"centralContacts":65,"locations":70,"responsibleParty":90,"collaborators":41,"id":92,"slug":41,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":41,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":41,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":41,"overallStatus":73,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Acotec Scientific Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Patency","Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.","6 month",[14,18,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Major adverse event (MAE) rate","Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR","30 days",{"measure":19,"description":20,"timeFrame":21},"Patency rate","Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.","12 months,24 months,36 months,48 months ,60 months",{"measure":23,"description":24,"timeFrame":21},"Rate of major target limb amputation","A major adverse limb event is defined as above-ankle amputation of the treated limb",{"measure":26,"description":27,"timeFrame":21},"Rate of All-cause mortality","All-cause mortality at 12, 24, 36, 48, 60 months post procedure",{"measure":29,"description":30,"timeFrame":21},"Rate of clinically-driven target vessel revascularization (CD-TVR)","Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure",{"measure":32,"description":33,"timeFrame":21},"Rate of clinically-driven target lesion revascularization (CD-TLR)","Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure",{"measure":35,"description":36,"timeFrame":21},"Rate of ulcer healing","Ulcer healed or not; if not, improving, stagnant,worsening",{"measure":38,"description":39,"timeFrame":40},"Rate of distal embolization","Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure","through procedure completion",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"DEB catheter","EXPERIMENTAL","Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm",[54],"Device: DEB catheter",[56],{"type":57,"name":50,"description":58,"armGroupLabels":59,"otherNames":41},"DEVICE","Trade name of DEB catheter: AcoArt Tulip (0.018\") or AcoArt Litos (0.014\")",[50],[61],{"name":62,"affiliation":63,"role":64},"Zhuang Baixi","Xiyuan Hospital of China Academy of Chinese Medical Sciences","PRINCIPAL_INVESTIGATOR",[66],{"name":62,"role":67,"phone":68,"phoneExt":41,"email":69},"CONTACT","010-62835122","zhuangbaixi@163.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Chui Yang Liu Hospital affiliated to Tsinghua University","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":80,"coordinates":81},"Point",[82,83],116.39723,39.9075,{"lat":83,"lon":82},[86],{"name":87,"role":67,"phone":88,"phoneExt":41,"email":89},"Yang Yongjiu","010-67700622","docyyj@126.com",{"type":91,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","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":102,"type":103},107,"ESTIMATED","INTERVENTIONAL",[43],"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.",[108],"Peripheral Artery Disease","2024-07-30",{"date":111,"type":112},"2024-08-01","ACTUAL",{"date":114,"type":112},"2021-12-31",{"date":116,"type":103},"2027-04-01",{"name":5,"class":6},1]