drugset / Trial / NCT05425056

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

NCT05425056

Phase 3 Completed 136 enrolled Vascular Therapies, Inc.
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2022-08-26
Primary completion
2025-03-18
Completion
2025-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule Other