[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stenosis-of-native-hemodialysis-arteriovenous-fistulas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stenosis-of-native-hemodialysis-arteriovenous-fistulas":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":19,"type":20},164,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26],"Stenosis of Native Hemodialysis Arteriovenous Fistulas","RECRUITING","2024-01-04",{"date":30,"type":31},"2024-01-16","ACTUAL",{"date":33,"type":31},"2023-02-20",{"date":35,"type":20},"2027-06",{"name":37,"class":38},"Acotec Scientific Co., Ltd","INDUSTRY",""]