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10-Year study tracks stent graft safety in 1,500 aortic patients

NCT ID NCT06658730

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 4 times

Summary

This study follows 1,500 people who received a GORE® TAG® stent graft to treat aortic conditions like aneurysms or dissections. Researchers will monitor device performance and patient outcomes for up to 10 years. The goal is to confirm that this minimally invasive procedure remains a safe and effective long-term option.

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 1,500 people

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

Started

Jun 2025

Expected to finish

Aug 2038

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 registry population is patients who are treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL at participating sites. This includes initial procedures and reinterventions (regardless of original intervention).

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. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements. 2. Patient has been or is intended to be treated with an eligible registry device.\* 3. Patient is age ≥ 18 years at time of informed consent signature. * The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable. Exclusion Criteria: 1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures. 2. Patient with exclusion criteria required by local law. 3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol. * The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).

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Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Dissection thoracic aortic aneurysm vascular disorder

As listed by the trial registrant

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

Aneurysm dissecting Aneurysm thoracic Dissection Dissection aortic aneurysm Dissection of aorta Intramural hematoma Transection aorta Vascular disease

How to take part

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

  1. The places running it

    37 sites in 10 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

  • AORN S.Anna e S. Sebastiano

    RECRUITING

    Caserta, Italy

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Baylor Research Institute

    RECRUITING

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Bristol NHS Foundation Trust

    RECRUITING

    Bristol, United Kingdom

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire Strasbourg

    RECRUITING

    Strasbourg, 67000, France

  • Columbia Medical Center of Plano

    RECRUITING

    Plano, Texas, 75075, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

  • IRCCS Policlinico di Milano

    RECRUITING

    Milan, Italy

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84157, United States

  • King Faisal Specialist Hospital and Research Center

    RECRUITING

    Riyāḑ, Saudi Arabia

  • Laiko General Hospital of Athens

    RECRUITING

    Athens, 11527, Greece

  • Leland Stanford Junior University

    RECRUITING

    Stanford, California, 94305, United States

  • MedStar Health, MedStar Washington Hospital Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Regensburg University Hospital

    RECRUITING

    Regensburg, D-93053, Germany

  • Rigshospitalet

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • Sentara Medical Group, Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23437, United States

  • The Hitchcock Foundation at Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Thomas Jefferson University

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Universitatsklinikum Ulm

    RECRUITING

    Ulm, D-89081, Germany

  • Universitatsmedizin Frankfurt

    RECRUITING

    Frankfurt, Germany

  • University Hospitals - Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Florida - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Maryland - Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Washington

    NOT_YET_RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Uppsala University

    RECRUITING

    Uppsala, SE-751 85, Sweden

More trials for these conditions

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