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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 is a Phase 3 study that has completed, run by Vascular Therapies. The registered enrollment target is 136 participants.

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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.

Interventions

  • DRUG Sirolimus

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2022-08-26
Est. Completion 2025-08-29
Phase Phase 3

Sponsor

Vascular Therapies

2 total trials

What the Registry Record Tells You About NCT05425056

The ClinicalTrials.gov registry entry for NCT05425056 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vascular Therapies, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.

NCT05425056 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.