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New Stent-Graft device under scrutiny for treating dangerous aortic aneurysms

NCT ID NCT07147569

Disease control Sponsor: W.L.Gore & Associates 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 100 people with thoracoabdominal or pararenal aortic aneurysms who receive the GORE EXCLUDER TAMBE device, a stent-graft system placed through blood vessels. Researchers will track how often the device is successfully implanted and works without leaks or serious complications over 12 months. The goal is to confirm the device's safety and effectiveness in real-world use.

What this could mean

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

Active substance
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (a stent-graft device)
What this could lead to
If successful, this could confirm that the device is a safe, effective option for treating complex aortic aneurysms without open surgery.
What could go wrong
This is an observational post-market study, not a randomized trial. Results may not apply to all patients, and risks include serious complications like stroke, paralysis, or kidney failure.

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 100 people

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

Started

Mar 2026

Expected to finish

Feb 2034

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 target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients who were attempted to implant the AC * Thoracoabdominal aortic aneurysm * Pararenal abdominal aortic aneurysm Exclusion Criteria: * N/A

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal thoracic aortic aneurysm

As listed by the trial registrant

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

Pararenal aortic aneurysm Thoracoabdominal aortic aneurysm

How to take part

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

  1. The places running it

    5 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

  • Morinomiya Hospital

    RECRUITING

    Osaka, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Japan

  • Osaka International Medical & Science Center Osaka Police Hospital

    RECRUITING

    Osaka, Japan

  • The Jikei University Hospital

    RECRUITING

    Minatoku, Japan

  • The University of Osaka Hospital

    RECRUITING

    Suita, Japan

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