[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VenoStent\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"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":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100516231",false,"NCT06001827","SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study","SAVE-FistulaS","Inclusion Criteria:\n\n* Age of at least 18 years\n* Referred for creation of a new AVF\n* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months\n\nExclusion Criteria:\n\n* Planned index procedure to revise or repair an existing fistula\n* Target artery inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Target vein inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound\n* Known central venous stenosis of at least 50% on the side of surgery\n* Presence of a stent or a stent graft within the access circuit\n* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation\n* Known or suspected active infection at the time of surgery\n* Congestive heart failure NYHA class 4\n* Prior steal on the side of surgery;\n* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study\n* Life expectancy less than 12 months\n* Expected to undergo kidney transplant surgery within 6 months of enrollment\n* Expected to undergo home hemodialysis\n* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening\n* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study\n* Unwillingness or inability to give consent and\u002For comply with the study follow up schedule\n* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.","ALL","18 Years",{"count":18,"type":19},600,"ESTIMATED","INTERVENTIONAL",[22],"NA","This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.",[25,26,27,28,29,30,31,32,33,34],"Chronic Kidney Diseases","End Stage Renal Disease","Arteriovenous Fistula","Hemodialysis Access Failure","ESRD","Vascular Access Complication","Renal Failure","Catheter Complications","Catheter Dysfunction","Renal Insufficiency",[36,37,38,39,40,41,42,43,44,26,27,45],"Vascular Surgery","Vascular Access","Nephrology","Bioabsorbable","Perivascular Wrap","External Support","Hemodialysis","Dialysis","Chronic Kidney Disease","AVF","RECRUITING","2026-02-12",{"date":49,"type":50},"2026-02-17","ACTUAL",{"date":52,"type":50},"2024-01-03",{"date":54,"type":19},"2029-12",{"name":56,"class":57},"VenoStent","INDUSTRY",28,""]