[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531882":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":19,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":19,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Acotec Scientific Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: DCB catheter",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Trade name of DCB catheter：Acoart Orchid＆Dhalia",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wang Yu Zhu","CONTACT","010-82693657","wangyuzhu@163.com",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Beijing Haidian Hospital","RECRUITING","Beijing","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":19,"phoneExt":19,"email":19},"Zhang Li Hong",{"type":43,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100531882","acoart-avf-renew-a-post-market-clinical-study-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":55,"type":56},164,"ESTIMATED","INTERVENTIONAL",[59],"NA","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).",[62],"Stenosis of Native Hemodialysis Arteriovenous Fistulas","2024-01-04",{"date":65,"type":66},"2024-01-16","ACTUAL",{"date":68,"type":66},"2023-02-20",{"date":70,"type":56},"2027-06",{"name":5,"class":6},1]