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 targetarm is under tourniquet pressure and anesthesia

• Target vein inner diameter < 2.0 mm, as measured by ultrasound while the target armis 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 bypreoperative 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 waspreviously 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) withoutdocumented current negative pregnancy test at screening

• Presence of a comorbid condition that, in the opinion of the Investigator, maysignificantly confound the collection of safety and efficacy data in this study

• Unwillingness or inability to give consent and/or comply with the study follow upschedule

• Any health condition, which in the opinion of the Investigator, would interfere withthe safety of the participant or the participant's ability to comply with the study.