The Access 2 Trial

The purpose of this study is to find out if the experimental drug, Sirolimus‑eluting Collagen Implant (also called the implant), is safe and effective in preventing or reducing the narrowing of the fistula where the implant is placed. The implant is an experimental drug because it has not been approved by the FDA for this use. After the fistula is successfully created, the implant is wrapped like a bandage around the outside of the vein and around the point where the artery and vein are joined.

In this study, once this implant is wrapped around the fistula by the surgeon, the sirolimus will be released from the implant. The action of the experimental drug may reduce the narrowing in the vein, which in turn may allow the vein to enlarge (mature), and become usable for hemodialysis. Reducing the chances of a narrowing may also reduce the need for additional surgical or other procedures that are performed to help keep the fistula open.

Inclusion Criteria:

Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:

1. Age 65 years or older

2. Able to provide written informed consent using a form that is approved by the Institutional Review Board (IRB) / Ethics Committee (EC)

3. Currently on hemodialysis for ≤12 months

4. Life expectancy of at least one year

5. In the opinion of the operating surgeon, vascular anatomy suitable for creation of a radiocephalic AV fistula

6. Successful creation of a single-stage radiocephalic end-to-side fistula

7. Willing to comply with the specified follow-up evaluations

Exclusion Criteria:

Subjects will be excluded if ANY of the following exclusion criteria apply:

1. Prior AV access created on the limb where the fistula surgery is planned

2. Planned start of peritoneal dialysis within 6 months of randomization

3. History of steal syndrome from a previous hemodialysis vascular access requiring intervention or access abandonment

4. Known hypersensitivity to the following: sirolimus, beef or bovine collagen

5. Hypotension with systolic blood pressures <100 mm Hg at the time of screening

6. Receiving anticoagulant therapy for non-cardiac indications

7. Known bleeding disorder.

8. Known to be HIV positive

9. Prisoner, mentally incompetent, and/or current alcohol or drug abuser

10. Currently participating in another investigational study