SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

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.