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NCT05425056 · ClinicalTrials.gov registry record · Phase 3
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
A Phase 3 study, sponsored by Vascular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT05425056: Completed Phase 3 study, sponsored by Vascular Therapies.
NCT05425056 is a Phase 3 study that has completed, run by Vascular Therapies. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05425056, a Phase 3 study, has completed, sponsored by Vascular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2025-08-29 |
| Phase | Phase 3 |
What the finished NCT05425056 record still lists
NCT05425056 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT05425056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05425056 about?
NCT05425056 is a clinical study titled "A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery". 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.
What is the current status of trial NCT05425056?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2022-08-26. Estimated completion is 2025-08-29.
What interventions are being tested in trial NCT05425056?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT05425056?
This trial is sponsored by Vascular Therapies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05425056's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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