SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

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 600 participants from up to 30 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.

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.