NCT05425056CompletedPhase 3
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 10 Jun 2022
- Start date
- 26 Aug 2022
- Primary completion date
- 18 Mar 2025
- Lead sponsor
- Vascular Therapies, Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT05425056
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 136
- From 26 Aug 2022 to the primary completion date, 18 Mar 2025
- 22 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior AV access created on the limb where the fistula surgery is planned
- Prisoner, mentally incompetent, and/or current alcohol or drug abuser
Other illness
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Known to be HIV positive
Other
- Planned start of peritoneal dialysis within 6 months of randomization
Who the study is looking for
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| St Helier Hospital Coordinator of this site? Confirm its status | Carshalton | United Kingdom | Unknown status |
| NHS Greater Glasgow and Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Barts Health NHS Trust, of Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| The Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Surgical Specialists of Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Arteries & Veins Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| James Eric Gardner, MD, PC Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| American Access Care of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sentara Norfolk General Hospital/Sentara Health Research Center Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| The Regional Medical Center/Dialysis Access Institute Coordinator of this site? Confirm its status | Orangeburg | United States | Unknown status |
| Veterans Affairs San Diego Health Center Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Houston Methodist Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| MedStar Cardiovascular Research Network at MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.