Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
SSB 11-02
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
1 other identifier
interventional
250
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedStudy Start
First participant enrolled
September 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2021
CompletedResults Posted
Study results publicly available
November 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedMarch 9, 2026
February 1, 2026
4.6 years
May 12, 2016
August 3, 2022
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Primary Endpoint Success for Zone 2
Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
12 Months
Study Arms (2)
Zone 2 Aneurysm
OTHERIncludes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Zone 2 Non-aneurysm
OTHERIncludes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Interventions
Endovascular repair with the TBE Device
Eligibility Criteria
You may qualify if:
- Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
- Age ≥18 years at time of informed consent signature
- Subject is capable of complying with protocol requirements, including follow-up
- Informed Consent Form (ICF) is signed by Subject or legal representative
- Must have appropriate proximal aortic landing zone.
- Must have appropriate target branch vessel landing zone
- For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
You may not qualify if:
- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Previous endovascular repair of the DTA with a non-Gore device
- Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
- Infected aorta
- Life expectancy \<2 years
- Myocardial infarction within 6 weeks prior to treatment
- 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.
- Patient has a systemic infection and may be at increased risk of endovascular graft infection
- Pregnant female at time of informed consent signature
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or medical device study within one year of study enrollment
- Known history of drug abuse within one year of treatment
- Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
- Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Keck Medical Center of USC
Los Angeles, California, 90033, United States
Cedar-Sinai Medical Center
Los Angeles, California, 90048, United States
Leland Stanford Junior University
Stanford, California, 94305-5407, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
University of Florida - Gainesville
Gainesville, Florida, 32610, United States
Univeristy of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46290, United States
University of Louisville Jewish Hospital
Louisville, Kentucky, 40202, United States
University or Maryland Baltimore
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Research Foundation SUNY Buffalo
Buffalo, New York, 14203, United States
Carolinas HealthCare Systems
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756, United States
Baylor College of Medicine - Houston
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann
Houston, Texas, 77030, United States
Heart Hospital at Baylor Plano
Plano, Texas, 75093, United States
Sentara Medical Group
Norfolk, Virginia, 23507, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin System
Madison, Wisconsin, 53792, United States
Related Publications (1)
Squiers JJ, DiMaio JM, Schaffer JM, Baxter RD, Gable CE, Shinn KV, Harrington K, Moore DO, Shutze WP, Brinkman WT, Gable DR. Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair. J Vasc Surg. 2022 Jun;75(6):1829-1836.e3. doi: 10.1016/j.jvs.2021.12.068. Epub 2022 Jan 5.
PMID: 34998942DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meier Hsu
- Organization
- W.L. Gore
Study Officials
- PRINCIPAL INVESTIGATOR
Michael M Dake, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Himanshu Patel, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 19, 2016
Study Start
September 6, 2016
Primary Completion
April 12, 2021
Study Completion (Estimated)
December 1, 2027
Last Updated
March 9, 2026
Results First Posted
November 22, 2022
Record last verified: 2026-02