Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

Last updated: February 11, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

GORE® TAG® Thoracic Branch Endoprosthesis

Clinical Study ID

NCT02777593
SSB 11-02 Pivotal (Zone 2)
  • Ages > 18
  • All Genders

Study 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, requiring Zone 2 proximal implantation of the device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Presence of thoracic aortic pathology deemed to warrant surgical repair whichrequires 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 aorticlanding zone.

Exclusion

Exclusion Criteria:

  1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aortarequiring 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 forAscending 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 developingclinical signs of focal (or global) disturbance of cerebral function, lasting morethan 24 hours or leading to death, with no apparent cause other than that ofvascular origin.

  9. Patient has a systemic infection and may be at increased risk of endovascular graftinfection

  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 studyenrollment

  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 archor ascending aorta

  15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheathinsertion 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 contrastmedia, which is not amenable to pre-treatment

  19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or knownhypersensitivity to heparin

  20. Patient with a history of a hypercoagulability disorder and/or hypercoagulabilitystate

  21. Diameter taper outside of the device sizing range between proximal and distallanding zones of aorta and the inability to use additional devices of differentdiameters 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 adequatevisualization of the aorta

  25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: GORE® TAG® Thoracic Branch Endoprosthesis
Phase:
Study Start date:
September 06, 2016
Estimated Completion Date:
December 31, 2027

Study Description

For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Heart Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Cedar-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Leland Stanford Junior University

    Stanford, California 94305-5407
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Health Research Institute

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

    Site Not Available

  • University of Florida - Gainesville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Univeristy of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • University of Louisville Jewish Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University or Maryland Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Research Foundation SUNY Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • Carolinas HealthCare Systems

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas 78756
    United States

    Site Not Available

  • Baylor College of Medicine - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Memorial Hermann

    Houston, Texas 77030
    United States

    Site Not Available

  • Heart Hospital at Baylor Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara Medical Group

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin System

    Madison, Wisconsin 53792
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.