save-fistulas: the selfwrap-assisted arteriovenous fistulas study

Conditions: Chronic Kidney Diseases; End Stage Renal Disease; Arteriovenous Fistula; Hemodialysis Access Failure; ESRD; Vascular Access Complication; Renal Failure; Catheter Complications; Catheter Dysfunction; Renal Insufficiency

Summary: 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.

this is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for ckd patients referred for creation of a new arteriovenous fistula (avf). this study will involve approximately 200 participants from up to 25 investigational sites, randomized 1:1 to treatment with the selfwrap or the untreated avf control (i.e. standard of care, soc). participants will be followed for a duration of 36 months.

Eligibility criteria:
inclusion criteria: * age of at least 18 years * referred for creation of a new avf * willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months exclusion criteria: * planned index procedure to revise or repair an existing fistula * target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * 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 * known central venous stenosis of at least 50% on the side of surgery * presence of a stent or a stent graft within the access circuit * known or suspected coagulation disorder that, in the opinion of the investigator, puts too much risk on the patient for avf creation * known or suspected active infection at the time of surgery * congestive heart failure nyha class 4 * prior steal on the side of surgery; * enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study * life expectancy less than 12 months * expected to undergo kidney transplant surgery within 6 months of enrollment * expected to undergo home hemodialysis * females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening * 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 * unwillingness or inability to give consent and/or comply with the study follow up schedule * 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.

Keywords: vascular surgery vascular access nephrology bioabsorbable perivascular wrap external support hemodialysis dialysis chronic kidney disease end stage renal disease arteriovenous fistula avf