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New stent graft under scrutiny for aortic repair in japan

NCT ID NCT07049913

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is checking how well a device called the GORE® TAG® Thoracic Branch Endoprosthesis works for people with a thoracic aortic aneurysm, dissection, or injury. About 200 patients in Japan who receive this stent graft will be followed to see if it is safe and effective. The main goals are to ensure the device can be placed successfully and to track any serious complications like stroke, paralysis, or device problems.

What this could mean

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

Active substance
GORE® TAG® Thoracic Branch Endoprosthesis (a stent graft device placed in the aorta to repair damage)
What this could lead to
If successful, this could confirm that the device is a safe and effective option for treating serious aortic conditions in the chest.
What could go wrong
This is a post-market surveillance study, not a randomized trial, so results may not apply to all patients. Risks include stroke, paralysis, kidney failure, or device complications.

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 200 people

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

Started

Dec 2025

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

Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.

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: * Those who are suitable for use of TBE according to the Japan package insert. \[Reference: Purpose of Use or Effects of TBE at the time of launch\] The GORE TAG Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery. * Thoracic aortic aneurysm, * Traumatic transection, and * Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy. Exclusion Criteria: * N/A

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Conditions

The condition(s) this trial relates to.

Aortic Dissection injury spinal cord injury thoracic aortic aneurysm

As listed by the trial registrant

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

Aneurysm thoracic Dissection of aorta, thoracic Trauma

How to take part

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

  1. The places running it

    1 site. 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

  • The University of Osaka Hospital

    RECRUITING

    Osaka, Suita, 565-0871, Japan

More trials for these conditions

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