A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery (ACCESS2)

STUDY OVERVIEW

This Phase 3 study is sponsored by Vascular Therapy, Inc. and aims to assess the efficacy and safety of the Sirolimus-eluting Collagen Implant (SeCI) during the creation of arteriovenous fistulas for hemodialysis access in subjects aged 65 years and older. Conducted across multiple centers, it involves a single-blind, controlled, randomized design, comparing subjects receiving the implant to those who do not. Approximately 120 subjects will be enrolled, with follow-up for one year post-surgery to evaluate outcomes.

STUDY GOALS

The goal of this Phase 3 study is to assess the efficacy and safety of the Sirolimus-eluting Collagen Implant (SeCI) during surgical creation of arteriovenous fistulas for hemodialysis access in subjects aged 65 years and older.

LOCATION

El Paso, Texas: Arteries & Veins El Paso

INCLUSION CRITERIA

  • Age 65 or older

  • Undergoing hemodialysis for 12 months or less

  • Successful creation of a single-stage radiocephalic end-to-side fistula

exclusion criteria

  • Previously created AV access in the planned limb

  • Planned start of peritoneal dialysis within 6 months

  • Known hypersensitivity to sirolimus, beef, or bovine collagen

  • HIV positive status

  • Ineligibility due to being a prisoner, mentally incompetent, or current alcohol or drug abuser

For more information, visit ClinicalTrials.gov.