Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
NCT ID: NCT02777593
Last Updated: 2025-02-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2016-09-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zone 2 Aneurysm
Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Zone 2 Non-aneurysm
Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Interventions
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GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Michael M Dake, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Himanshu Patel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Keck Medical Center of USC
Los Angeles, California, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
Leland Stanford Junior University
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Univeristy of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
University of Louisville Jewish Hospital
Louisville, Kentucky, United States
University or Maryland Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Research Foundation SUNY Buffalo
Buffalo, New York, United States
Carolinas HealthCare Systems
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Baylor College of Medicine - Houston
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann
Houston, Texas, United States
Heart Hospital at Baylor Plano
Plano, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin System
Madison, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SSB 11-02 Pivotal (Zone 2)
Identifier Type: -
Identifier Source: org_study_id
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