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New wrap could save kidney patients from dialysis disasters

NCT ID NCT06001827

Disease control Sponsor: VenoStent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special wrap called SelfWrap that is placed around blood vessels during surgery to create a connection for dialysis. The wrap helps the vessels grow strong and work well without extra procedures. About 600 adults with advanced kidney disease who need a new dialysis access will take part. The goal is to see if the wrap reduces complications and helps the vessels mature faster.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

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: * Age of at least 18 years * Referred for creation of a new AVF * Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months Exclusion Criteria: * Planned index procedure to revise or repair an existing fistula * Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound * Known central venous stenosis of at least 50% on the side of surgery * Presence of a stent or a stent graft within the access circuit * Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation * Known or suspected active infection at the time of surgery * Congestive heart failure NYHA class 4 * Prior steal on the side of surgery; * Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study * Life expectancy less than 12 months * Expected to undergo kidney transplant surgery within 6 months of enrollment * Expected to undergo home hemodialysis * Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening * Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study * Unwillingness or inability to give consent and/or comply with the study follow up schedule * Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Arteriovenous fistula Catheter complications Catheter dysfunction Chronic kidney diseases End-stage renal disease ESRD Hemodialysis access failure Renal failure Renal insufficiency Vascular access complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A&V Doctors PLLC

    RECRUITING

    El Paso, Texas, 79912, United States

  • AKDHC Bullhead City

    RECRUITING

    Bullhead City, Arizona, 86442, United States

  • AKDHC Marana Surgery Center

    RECRUITING

    Marana, Arizona, 85658, United States

  • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Banner University Medical Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Houston Methodist Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • Houston Methodist Research Institute (Sugar Land)

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • James Eric Gardner, MD, PC

    RECRUITING

    Memphis, Tennessee, 38115, United States

  • Lutheran Medical Group

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • MUSC Black River

    RECRUITING

    Florence, South Carolina, 29505, United States

  • MUSC Charleston

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • Northwell Health

    RECRUITING

    Lake Success, New York, 11042, United States

  • Orange County Vascular Access Center

    RECRUITING

    Garden Grove, California, 92840, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Saint David's HealthCare Partnership, L.P., LLP

    RECRUITING

    Austin, Texas, 78701, United States

  • Saint Louis University

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Spartanburg Regional Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29650, United States

  • Surgical Associates of Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Surgical Specialists of Charlotte, P.A.

    RECRUITING

    Charlotte, North Carolina, 28226, United States

  • Tallahassee Research Institute

    RECRUITING

    Tallahassee, Florida, 32308, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • Upper Valley Dialysis Access Center, LLC

    RECRUITING

    Mission, Texas, 78572, United States

  • Vascular Care of South Carolina

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.