Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

Inclusion Criteria: * Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula. * Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound * Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula Exclusion Criteria: * Prior AV access created on the limb where the fistula surgery is planned * ST-elevation MI or cerebrovascular accident within 30 days of the index procedure * Known hypersensitivity to the following: sirolimus, beef or bovine collagen * Hypotension with systolic blood pressures \<100 mm Hg at the time of screening * Known or suspected active infection at the time of the AV fistula surgery * Known to be HIV positive * Prisoner, mentally incompetent, and/or alcohol or drug abuser