SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

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 …