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Evaluation of the GORE® TAG® thoracic branch endoprosthesis (TBE device) in the treatment of lesions of the aortic arch and descending thoracic aorta, zone 0/1

NCT ID NCT02777528

NEW 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

79 people

The number who actually took part.

Start date

Aug 2016

Expected to finish

Mar 2028

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.

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. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2. 2. Age ≥18 years at time of informed consent signature 3. Subject is capable of complying with protocol requirements, including follow-up 4. Informed Consent Form (ICF) is signed by Subject or legal representative 5. Must have appropriate proximal aortic landing zone. 6. Must have appropriate target branch vessel landing zone. 7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone. 8. Native aortic valve (Zone 0/1 subjects only) 9. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only) Exclusion Criteria: 1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair 2. Previous endovascular repair of the ascending aorta 3. Previous endovascular repair of the DTA with a non-Gore device 4. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access. 5. Infected aorta 6. Life expectancy \<2 years 7. Myocardial infarction within 6 weeks prior to treatment 8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin. 9. Patient has a systemic infection and may be at increased risk of endovascular graft infection 10. Pregnant female at time of informed consent signature 11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 12. Participation in another drug or medical device study within one year of study enrollment 13. Known history of drug abuse within one year of treatment 14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta 15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access 16. Planned coverage of celiac artery 17. Patient has known sensitivities or allergies to the device materials 18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability state 21. Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper 22. Mycotic aneurysm 23. Persistent refractory shock (systolic blood pressure \<90 mm Hg) 24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta 25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \<30 or currently requiring dialysis 26. Patient at high risk of neurological event, e.g. stroke

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Conditions

The condition(s) this trial relates to.

thoracic aortic aneurysm

As listed by the trial registrant

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

Aorta; lesion Aortic aneurysm, thoracic

Contacts and locations

Locations

  • Baylor College of Medicine - Houston

    Houston, Texas, 77030, United States

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756, United States

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee, 38120, United States

  • Carolinas HealthCare Systems

    Charlotte, North Carolina, 28203, United States

  • Cedar-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Dartmouth-Hitchock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Heart Hospital at Baylor Plano

    Plano, Texas, 75093, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Jikei Medical University Hospital

    Tokyo, Japan

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • Leland Stanford Junior University

    Stanford, California, 94305-5407, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Hospital Center

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

  • Memorial Hermann

    Houston, Texas, 77030, United States

  • Morinomiya Hospital

    Osaka, Japan

  • Nagoya University Hospital

    Aichi, Japan

  • Northwesten University

    Chicago, Illinois, 60611, United States

  • Oita University Hospital

    Ōita, Japan

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka University Hospital

    Osaka, Japan

  • Research Foundation SUNY Buffalo

    Buffalo, New York, 14203, United States

  • Sentara Medical Group

    Norfolk, Virginia, 23507, United States

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46290, United States

  • University of Baltimore Maryland

    Baltimore, Maryland, 21201, United States

  • University of Florida-Gainesville

    Gainesville, Florida, 32610, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • University of Wisconsin System

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington Univeristy School of Medicine - St Louis

    St Louis, Missouri, 63110, United States

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