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A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Sponsor: Vascular Therapies, Inc.
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 surgical creation of an arteriovenous fistula for hemodialysis vascular access.
Official title: 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)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2022-08-26
Completion Date
2025-08-29
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Sirolimus
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
Locations (22)
Veterans Affairs San Diego Health Center
San Diego, California, United States
Lundquist Institute for Biomedical Innovation
Torrance, California, United States
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
American Access Care of Miami
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
The Regional Medical Center/Dialysis Access Institute
Orangeburg, South Carolina, United States
James Eric Gardner, MD PC
Memphis, Tennessee, United States
Arteries & Veins
El Paso, Texas, United States
Houston Methodist
Houston, Texas, United States
Houston Methodist
Sugar Land, Texas, United States
Sentara Norfolk General Hospital/Sentara Health Research Center
Norfolk, Virginia, United States
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
St Helier Hospital
Carshalton, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Barts Health NHS Trust of Royal London Hospital
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom