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New mesh tube aims to prevent dialysis vein blockages

NCT ID NCT06807099

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a device called WRAPSODY CIE, a mesh tube placed in veins used for dialysis. The goal is to see if it can keep these veins from narrowing or blocking over time. Researchers will follow 250 people on dialysis for up to 3 years to check how well the device works and if it is safe.

What this could mean

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

Active substance
WRAPSODY Cell Impermeable Endoprosthesis (a mesh tube placed in the vein to keep it open)
What this could lead to
If successful, this device could help people on dialysis avoid repeated procedures to unblock their veins, making treatment easier and more reliable.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device may not work for everyone and carries risks like clotting or infection.

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 250 people

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

Started

Jul 2025

Expected to finish

Jul 2030

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

Subjects with stenosis or occlusion within the dialysis outflow circuit who meet the inclusion and exclusion criteria are intended to participate in this study. The eligibility criteria are kept to a minimum to better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases or anatomies.

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 36 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 and is treated with WRAPSODY CIE 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 or titanium. 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 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.

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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

How to take part

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

  1. The places running it

    15 sites in 2 countries. 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

  • AKDHC Phoenix Surgery Center

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • American Access Care of Jacksonville

    RECRUITING

    Jacksonville, Florida, 32218, United States

  • American Access Care of Rhode Island

    RECRUITING

    Providence, Rhode Island, 02906, United States

  • Apex Research of Riverside

    RECRUITING

    Riverside, California, 92505, United States

  • Bluff City Vascular

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38104, United States

  • Centre Hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Humble Vascular Surgical Center

    RECRUITING

    Humble, Texas, 77338, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • Sarasota Memorial Research Institute

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sentara Vascular Specialists

    RECRUITING

    Virginia Beach, Virginia, 23507, United States

  • Spartanburg Medical System

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Texas Research Institute

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Trinity Research Group

    RECRUITING

    Dothan, Alabama, 36301, United States

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

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