A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Sponsored by Vascular Therapies, Inc.
About this trial
Last updated 2 years ago
Study ID
VT-305
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
65+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 months ago
What is this trial about?
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen
implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at
the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
What are the participation requirements?
Inclusion Criteria
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
Exclusion Criteria
- Prior AV access created on the limb where the fistula surgery is planned
- Planned start of peritoneal dialysis within 6 months of randomization
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Known to be HIV positive
- Prisoner, mentally incompetent, and/or current alcohol or drug abuser