[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531882":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":39,"overallOfficials":25,"centralContacts":44,"locations":50,"responsibleParty":66,"collaborators":25,"id":68,"slug":25,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Acotec Scientific Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Target Lesion Primary Patency Rate","Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.","6 months",{"measure":14,"description":15,"timeFrame":16},"Serious Adverse Event Rate","Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.","30 days",[18,21],{"measure":10,"description":19,"timeFrame":20},"Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.","12 months，24 months",{"measure":22,"description":23,"timeFrame":24},"All-cause mortality Rate","All-cause mortality post procedure","24 months",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"DCB catheter","EXPERIMENTAL","Using DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae.",[38],"Device: DCB catheter",[40],{"type":41,"name":34,"description":42,"armGroupLabels":43,"otherNames":25},"DEVICE","Trade name of DCB catheter：Acoart Orchid＆Dhalia",[34],[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Wang Yu Zhu","CONTACT","010-82693657","wangyuzhu@163.com",[51],{"facility":52,"status":53,"city":54,"state":25,"zip":25,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Beijing Haidian Hospital","RECRUITING","Beijing","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":25,"phoneExt":25,"email":25},"Zhang Li Hong",{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100531882",false,"NCT06205576","ACOART AVF RENEW: A Post Market Clinical Study","A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)","Inclusion Criteria:\n\n* Patient is ≥18 and ≤85 years of age\n* The target AV fistula has undergone successful dialysis for at least 1 time\n* Patient has a de novo and\u002For non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）\n* Patient has a de novo and\u002For non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：\n\n  * The physical examination was abnormal\n  * Significant increase in dynamic venous pressure\n  * Blood flow decreased significantly\n* Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length\n* Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:\n\n  * Residual stenosis of ≤ 30% AND\n  * Absence of a flow limiting dissection (Grade ≥C) or perforation\n* Patient provides written informed consent prior to enrollment in the study\n\nExclusion Criteria:\n\n* Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children\n* Dialysis access is located in the lower extremity\n* More than one lesion\n* Patient with hemodynamically significant central venous stenoses\n* Patient has presence of a stent located in the target AV access circuit\n* Patient has undergone prior intervention of access site within 30 days of index procedure\n* Patient with target AVF or access circuit which previously had or currently has a plan to surgery\n* Patient who cannot receive recommended antiplatelet and\u002For anticoagulant therapy\n* Patients undergoing immunotherapy or suspected\u002Fconfirmed vasculitis\n* Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type\n* Patient has an infected AV access or systemic infection\n* Patient has a life expectancy of \\\u003C24 months\n* Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis\n* Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him\u002Fher to be non-compliant with the protocol or confound the data interpretation\n* Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study","ALL","18 Years","85 Years",{"count":78,"type":79},164,"ESTIMATED","INTERVENTIONAL",[27],"The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).",[84],"Stenosis of Native Hemodialysis Arteriovenous Fistulas","2024-01-04",{"date":87,"type":88},"2024-01-16","ACTUAL",{"date":90,"type":88},"2023-02-20",{"date":92,"type":79},"2027-06",{"name":5,"class":6},1]