Cure My Disease

Don't miss your cure!

 Log in / Sign up

New stent aims to keep dialysis lifelines flowing

NCT ID NCT05062291

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a special stent called WRAPSODY used to treat narrowed or blocked veins in people on dialysis. About 500 participants will be followed for up to 24 months to see how well the stent keeps the access site open and safe. The goal is to improve long-term dialysis care.

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.

Participants

About 500 people

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

Started

Jun 2022

Expected to finish

Oct 2027

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.

Who is studied

The registry will include peripheral cases in both AV graft and AV fistula patients (including at the graft vein anastomosis of an AVG patient) and thoracic central patients in both AV graft and AV fistula patients.

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: 1. Subject provides written informed consent for study participation. 2. Subject is male or female, with an age ≥ 18 years at date of enrollment. 3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months. 4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon 5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session. 6. Subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use. Exclusion Criteria: 1. Subject has a planned surgical revision of access site. 2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. 3. Subject has an uncorrectable coagulation disorder. 4. Known hypersensitivity to nickel titanium alloy. 5. Subject's hemodialysis access is anticipated to be abandoned within 6 months. 6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure. 7. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation. 8. Device would be placed in the Superior Vena Cava 9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

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.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Afya Hospital

    Brasília, Brazil

  • Belfast City Hospital, Belfast Health and Social Care Trust

    Belfast, United Kingdom

  • CHUC - Centro Hospitalar e Universitário De Coimbra

    Coimbra, Portugal

  • Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz

    São Paulo, Brazil

  • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, United Kingdom

  • Complexo Hospitalar de Niterói

    Niterói, Brazil

  • Fiona Stanley Hospital

    Murdoch, Australia

  • Hospital Da Bahia

    Salvador, Brazil

  • Hospital Felicio Rocho

    Belo Horizonte, Brazil

  • Hospital Santa Lucia

    Brasília, Brazil

  • Hospital Santa Rita de Cassia

    São Paulo, Brazil

  • Hospital Vera Cruz

    Campinas, Brazil

  • Impar Servicos Hospitalares S/A - Hospital Sao Lucas

    Rio de Janeiro, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, Brazil

  • Instituto Pro Renal

    Curitiba, Brazil

  • King's College Hospital, NHS Foundation Trust

    London, United Kingdom

  • Liverpool Hospital

    Liverpool, Australia

  • Maastricht UMC+

    Maastricht, Netherlands

  • Monash Health

    Clayton, Australia

  • Parana Medical Research Center

    Paranã, Brazil

  • Princess Alexandra Hospital

    Woolloongabba, Australia

  • Protestant Hospital Queen Elisabeth Herzberge

    Berlin, Germany

  • Queen Elizabeth Hospital, University Hospital Birmingham

    Birmingham, United Kingdom

  • Real Hospital Português de Beneficência em Pernambuco

    Recife, Brazil

  • Rio de Janeiro State University

    Rio de Janeiro, Brazil

  • Royal Berkshire NHS Foundation Trust

    Reading, United Kingdom

  • Royal London Hospital, Barts Health NHS Trust

    London, United Kingdom

  • Shaare Zedek Medical Center

    Jerusalem, Israel

  • Sir Charles Gairdner Hospital

    Nedlands, Australia

  • Te Toka Tumai Auckland

    Auckland, New Zealand

  • Te Whatu Ora Health NZ Waitaha Canterbury

    Christchurch, New Zealand

  • Te Whatu Ora Health NZ Waitemata

    Auckland, New Zealand

  • Te Whatu Ora Health New Zealand Waitemata

    Hamilton, New Zealand

  • The General University Hospital of Patras

    Rio, Greece

  • University of Cologne

    Cologne, Germany

More trials for these conditions

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