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New implant could speed up dialysis fistula maturation

NCT ID NCT05425056

Disease control Sponsor: Vascular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This phase 3 trial tests a sirolimus-releasing collagen implant placed around a new dialysis fistula during surgery. The goal is to help the fistula mature faster so it can be used for dialysis. The study involves 136 people aged 65+ with kidney failure who are new to hemodialysis. Results will compare fistula maturation and long-term usability between those who get the implant and those who don't.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus-eluting collagen implant (Sirogen)
What this could lead to
If it works, this implant could help dialysis patients get a working fistula sooner and reduce complications.
What could go wrong
This is a small, early-phase 3 trial with only 136 participants. The implant may not improve fistula outcomes and carries risks like infection or allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

136 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 65 years or older * Currently on hemodialysis for ≤12 months * Successful creation of a single stage radiocephalic end to side fistula Exclusion Criteria: * Prior AV access created on the limb where the fistula surgery is planned * Planned start of peritoneal dialysis within 6 months of randomization * Known hypersensitivity to the following: sirolimus, beef or bovine collagen * Known to be HIV positive * Prisoner, mentally incompetent, and/or current alcohol or drug abuser

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome congenital arteriovenous fistula dialysis disequilibrium syndrome end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriovenous fistula Chronic kidney failure Complication of hemodialysis Complication of renal dialysis End-stage kidney disease End-stage renal disease ESRD Vascular access complication

Contacts and locations

Locations

  • American Access Care of Miami

    Miami, Florida, 33156, United States

  • Arteries & Veins

    El Paso, Texas, 79912, United States

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Barts Health NHS Trust of Royal London Hospital

    London, United Kingdom

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Houston Methodist

    Sugar Land, Texas, 77479, United States

  • James Eric Gardner, MD PC

    Memphis, Tennessee, 38115, United States

  • Lundquist Institute for Biomedical Innovation

    Torrance, California, 90502, United States

  • MedStar Cardiovascular Research Network at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Sentara Norfolk General Hospital/Sentara Health Research Center

    Norfolk, Virginia, 23507, United States

  • St George's University Hospitals NHS Foundation Trust

    London, United Kingdom

  • St Helier Hospital

    Carshalton, SM5 1AA, United Kingdom

  • Surgical Specialists of Charlotte

    Charlotte, North Carolina, 28207, United States

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • The Regional Medical Center/Dialysis Access Institute

    Orangeburg, South Carolina, 29118, United States

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, United Kingdom

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • Veterans Affairs San Diego Health Center

    San Diego, California, 92161, United States

More trials for these conditions

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