Marana

Researchers are evaluating a new device called SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease who need a new arteriovenous fistula (AVF) created. The trial aims to assess the safety and effectiveness of SelfWrap in helping the AVF mature without assistance within 180 days and to monitor for any access-related complications within 30 days. This is a multi-center, randomized, single-blind clinical trial involving about 600 participants across up to 30 sites. Participants are randomly assigned to one of two groups: one group will receive the SelfWrap device applied during their AVF creation surgery, which aims to provide mechanical support to improve fistula maturation and durability; the control group will undergo the standard AVF creation surgery without the device. The study follows participants for 36 months to gather long-term data on the outcomes and safety of the device compared to standard care. During the study, participants will attend follow-up visits over three years to assess their fistula maturation status and monitor for any complications. Researchers will evaluate the primary outcomes including unassisted maturation within 6 months and freedom from access-related adverse events within 30 days after surgery. Participants must be willing and able to communicate with the study team and comply with the study schedule to provide ongoing data for safety and effectiveness analysis.