Marana

Researchers are evaluating the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease CKD who are referred for creation of a new arteriovenous fistula AVF. This multi-center, prospective, randomized, double-arm, single-blind clinical trial involves about 600 participants across up to 30 sites. The purpose is to compare SelfWrap-assisted AVF creation with the standard surgical procedure without any additional intervention over a 36-month follow-up period. Participants are randomly assigned to one of two groups one receiving the SelfWrap device during AVF creation surgery, and the other undergoing the usual AVF surgery without intervention as a control group. The SelfWrap device offers mechanical support intended to improve the maturation and patency of the fistula. The trial follows participants for 36 months after surgery to monitor outcomes. During the study, participants will undergo assessments to measure unassisted maturation of the AVF at up to 6 months and monitor freedom from access-related adverse events through 30 days. Researchers will evaluate safety and effectiveness through these primary outcome measures. Participants are expected to comply with study requirements and attend follow-up visits throughout the 36-month period to allow comprehensive evaluation of the devices impact and any complications.