Status:
COMPLETED
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Lead Sponsor:
Vascular Therapies, Inc.
Conditions:
Complication of Renal Dialysis
End Stage Renal Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 surgica...
Detailed Description
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are...
Eligibility Criteria
Inclusion
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05425056
Start Date
August 26 2022
End Date
August 29 2025
Last Update
September 24 2025
Active Locations (22)
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1
Veterans Affairs San Diego Health Center
San Diego, California, United States, 92161
2
Lundquist Institute for Biomedical Innovation
Torrance, California, United States, 90502
3
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
American Access Care of Miami
Miami, Florida, United States, 33156