Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New stent graft aims to keep dialysis veins open longer

NCT ID NCT04540302

Disease control Sponsor: Merit Medical Systems, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special stent graft (WRAPSODY) against the usual balloon treatment for vein blockages in people on dialysis. The goal was to see if the stent graft could keep the vein open longer and reduce the need for repeat procedures. A total of 357 patients took part across multiple centers.

What this could mean

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

Active substance
WRAPSODY Endovascular Stent Graft
What this could lead to
If successful, this stent graft could help dialysis patients keep their vein access open longer, reducing the need for repeat procedures.
What could go wrong
This is a completed study, but results may not apply to all patients. Stent grafts carry risks like clotting or infection, and the device may not outperform standard treatment.

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

357 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 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

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: * Subject provides written informed consent * Subject is male or female, with an age ≥ 18 years at date of enrollment. * Subject is willing to undergo all follow-up assessments. * Subject has a life expectancy ≥ 12 months. * Subject is undergoing chronic hemodialysis. * Subject has either a mature AVF or AVG in the arm. * Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion. * Target lesion has ≥50% stenosis. * Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm Exclusion Criteria: * Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. * Subject has a stroke diagnosis within 3 months prior to enrollment. * Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment. * Subject is pregnant, breastfeeding, or intending to become pregnant within the next year. * Target lesion is located within a stent / stent graft.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Venous occlusion are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

congenital arteriovenous fistula vascular occlusion disorder

As listed by the trial registrant

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

Venous occlusion Venous stenosis

Contacts and locations

Locations

  • Brigham and Women's Faulkner Hospital

    West Roxbury, Massachusetts, 02130, United States

  • CDVA

    Pasadena, Texas, 77504, United States

  • Charlotte Radiology

    Charlotte, North Carolina, 28202, United States

  • Chicago Access Center

    Chicago, Illinois, 60559, United States

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Coastal Vascular and Interventional

    Pensacola, Florida, 32504, United States

  • Dallas Nephrology Associates

    Plano, Texas, 75093, United States

  • Dorset County Hospital

    Dorchester, United Kingdom

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Global Kidney Associates

    Houston, Texas, 77008, United States

  • Hospital Universitário Pedro Ernesto

    Rio de Janeiro, Brazil

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Indiana University Hospital and Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, Brazil

  • Instituto Santa Marta De Ensino E Pesquisa

    Brasília, Brazil

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101, United States

  • Leesburg Vascular Access Center & Discovery Medical Research

    Oscala, Florida, 34471, United States

  • Lister Hospital

    Stevenage, SG1 4AB, United Kingdom

  • Michigan Vascular Access Center

    Flint, Michigan, 48507, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • Nephrology Associates

    Newark, Delaware, 19713, United States

  • North Carolina Nephrology Raleigh Access

    Raleigh, North Carolina, 27610, United States

  • Northwestern Medical Center

    Chicago, Illinois, 60611, United States

  • Open Access Miami, LLC

    Miami, Florida, 33169, United States

  • PPG Health PA, DBA-Tarrant Vascular

    Fort Worth, Texas, 76104, United States

  • Pima Heart and Vascular

    Tucson, Arizona, 85718, United States

  • Prisma Health System Upstate

    Greenville, South Carolina, 29605, United States

  • Providence Access Center

    Providence, Rhode Island, 02906, United States

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Real Hospital Português de Beneficência em Pernambuco

    Recife, Brazil

  • Renal Disease Research Institute

    Dallas, Texas, 75235, United States

  • Royal London Hospital

    London, E1 1FR, United Kingdom

  • Sentara Vascular Specialists

    Virginia Beach, Virginia, 23507, United States

  • Soltero Cardiovascular Research Center

    Dallas, Texas, 75226, United States

  • Southwest Kidney institute (SKI) Vascular Center

    Tempe, Arizona, 85281, United States

  • St. Joseph Hospital

    Orange, California, 92868, United States

  • Toronto General Hospital

    Toronto, Canada

  • UNC Health

    Chapel Hill, North Carolina, 27599, United States

  • University Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Health - Memorial Hermann Katy Hospital

    Katy, Texas, 77494, United States

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States

  • Vascular Institute of Atlantic Medical Imaging

    Vineland, New Jersey, 80360, United States

More trials for these conditions

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