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

A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.

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