A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Public ClinicalTrials.gov record NCT05425056. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05425056
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 136 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2022 (Actual)
- Primary completion
- Mar 18, 2025 (Actual)
- Completion
- Aug 29, 2025 (Actual)
- Last update posted
- Oct 6, 2026
2022 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Veterans Affairs San Diego Health Center | San Diego | California | 92161 | — |
| Lundquist Institute for Biomedical Innovation | Torrance | California | 90502 | — |
| MedStar Cardiovascular Research Network at MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| American Access Care of Miami | Miami | Florida | 33156 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| The Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Atrium Health | Charlotte | North Carolina | 28204 | — |
| Surgical Specialists of Charlotte | Charlotte | North Carolina | 28207 | — |
| The Regional Medical Center/Dialysis Access Institute | Orangeburg | South Carolina | 29118 | — |
| James Eric Gardner, MD PC | Memphis | Tennessee | 38115 | — |
| Arteries & Veins | El Paso | Texas | 79912 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Houston Methodist | Sugar Land | Texas | 77479 | — |
| Sentara Norfolk General Hospital/Sentara Health Research Center | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05425056, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05425056 live on ClinicalTrials.gov.