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New implant could keep dialysis lifelines open longer

NCT ID NCT02513303

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 2 times

Summary

This study tested a special collagen implant coated with sirolimus (rapamycin) placed around a new dialysis fistula during surgery. The goal was to see if it helps the fistula become usable for dialysis sooner and stay working longer. About 269 people with advanced kidney disease who needed or were about to start dialysis took part. The implant is designed to reduce scarring and improve blood flow.

What this could mean

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

Active substance
Sirolimus (also known as Rapamycin) delivered via a collagen implant placed around the fistula during surgery
What this could lead to
If successful, this implant could help dialysis fistulas work better and last longer, reducing the need for repeat surgeries.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. The implant may not improve fistula function enough to change standard care, and there could be risks like infection or scarring.

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

269 people

The number who actually took part.

Start date

Nov 2015

Finished

Jun 2021

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

18 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: * Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula. * Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound * Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula Exclusion Criteria: * Prior AV access created on the limb where the fistula surgery is planned * ST-elevation MI or cerebrovascular accident within 30 days of the index procedure * Known hypersensitivity to the following: sirolimus, beef or bovine collagen * Hypotension with systolic blood pressures \<100 mm Hg at the time of screening * Known or suspected active infection at the time of the AV fistula surgery * Known to be HIV positive * Prisoner, mentally incompetent, and/or 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

  • AKDHC Medical Research Service

    Phoenix, Arizona, 85012, United States

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805, United States

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017, United States

  • San Diego Institute of Medical Research

    Escondido, California, 92025, United States

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