End Stage Renal Disease Clinical Trial
— ACCESS2Official 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)
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 | Recruiting |
Enrollment | 120 |
Est. completion date | September 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
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 States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | Emory University Hospital Midtown | Atlanta | Georgia |
United States | Augusta University | Augusta | Georgia |
United States | The Brigham and Women's Hospital | Boston | Massachusetts |
United States | Atrium Health | Charlotte | North Carolina |
United States | Surgical Specialists of Charlotte | Charlotte | North Carolina |
United States | Arteries & Veins | El Paso | Texas |
United States | Houston Methodist | Houston | Texas |
United States | University of Louisville | Louisville | Kentucky |
United States | James Eric Gardner, MD PC | Memphis | Tennessee |
United States | American Access Care of Miami | Miami | Florida |
United States | Yale University | New Haven | Connecticut |
United States | Mount Sinai Hospital | New York | New York |
United States | Sentara Norfolk General Hospital/Sentara Health Research Center | Norfolk | Virginia |
United States | The Regional Medical Center/Dialysis Access Institute | Orangeburg | South Carolina |
United States | Veterans Affairs San Diego Health Center | San Diego | California |
United States | Houston Methodist | Sugar Land | Texas |
United States | Lundquist Institute for Biomedical Innovation | Torrance | California |
United States | MedStar Cardiovascular Research Network at MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Vascular Therapies, Inc. |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Fistula Maturation (FM) | Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization.
The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time [defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)]. |
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