[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arteriovenous-fistula-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arteriovenous-fistula-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100627760","phase-1-safety-and-efficacy-study-of-human-umbilical-cord-mesenchymal-stem-cells-in-preventing-arteriovenous-fistula-stenosis-in-patients-with-end-stage-diabetic-kidney-disease-100627760",false,"NCT07452822","Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diabetic nephropathy with estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin·1.73m²;\n2. Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;\n3. Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;\n4. Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;\n2. Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;\n3. Patients with a history of pacemaker implantation;\n4. Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;\n5. Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;\n6. Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period;\n7. Any other conditions deemed inappropriate by the investigator for enrollment in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis",[28],"Arteriovenous Fistula Stenosis","NOT_YET_RECRUITING","2026-03-01",{"date":32,"type":33},"2026-03-05","ACTUAL",{"date":35,"type":21},"2026-02-20",{"date":37,"type":21},"2028-03-30",{"name":39,"class":40},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100548580","peripheral-scoring-drug-coated-balloon-in-the-treatment-of-hemodialysis-arteriovenous-fistula-stenosis-100548580","NCT06422845","Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis","A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis","SCDB","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years old;\n2. The patient's AVF\u002FAVG is mature and has successfully completed hemodialysis at least once;\n3. The target lesion is located at the AVF\u002FAVG return vein and venous side anastomosis;\n4. Hemodynamically significant AVF\u002FAVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \\\u003C 600 ml\u002Fmin or decreased by 25% compared with the previous follow-up visit, etc.;\n5. The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);\n6. Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;\n7. The patient voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;\n2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;\n3. Calcified lesions that are not expected to be expandable with balloons;\n4. Patients with thrombosis at the access stenosis site;\n5. The target lesion is located at the blood supply artery and arterial anastomosis;\n6. Patients known to be allergic to or intolerant to contrast media and paclitaxel;\n7. The patient's life expectancy is less than 2 years;\n8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;\n9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;\n10. Vascular access infection or systemic active infection;\n11. Those who have participated in unfinished clinical trials of other drugs or devices;\n12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study.","80 Years",{"count":51,"type":21},328,[53],"NA","This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.",[28],[57,58,59,60],"arteriovenous fistula stenosis","scoring","hemodialysis","drug-coated balloon","RECRUITING","2025-01-07",{"date":64,"type":33},"2025-01-09",{"date":66,"type":33},"2024-09-30",{"date":68,"type":21},"2027-07",{"name":70,"class":40},"DK Medical Technology (Suzhou) Co., Ltd.",33,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100558617","phase-3-randomised-clinical-trial-comparing-drug-coated-balloon-to-plain-balloon-for-all-peripheral-avf-stenosis-100558617","NCT06553443","Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis","RANGER","Inclusion Criteria:\n\n1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.\n2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).\n3. Less than 30% residual stenosis after angioplasty.\n4. ≥ 21 years old\n5. Informed and valid consent given.\n\nExclusion Criteria:\n\n1. Thrombosed AVFs\n2. Haemodynamically significant central vein stenosis\n3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)\n4. Contraindication to antiplatelet therapy\n5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.\n6. Allergy \u002F contraindication to paclitaxel.\n7. Acute infection over proposed puncture site.\n8. Women who are breastfeeding, pregnant \\* or planning on becoming pregnant during study.\n9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.\n10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.","21 Years",{"count":81,"type":21},94,[83],"PHASE3","To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty",[86,28,87],"Arteriovenous Fistula","Dialysis Access Malfunction",[60,89],"access circuit patency","2024-08-11",{"date":92,"type":33},"2024-08-14",{"date":94,"type":33},"2024-01-04",{"date":96,"type":21},"2029-12-31",{"name":98,"class":99},"Singapore General Hospital","OTHER",1]