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)



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:August 2016
End Date:July 2024
Contact:Nick Pirooz, MHA
Email:npirooz@wlgore.com
Phone:623-234-5519

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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

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.


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
We found this trial at
40
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Thomas Naslund, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Brad Leshnower, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Adam Beck, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Cambria, MD
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Gainesville, Florida 32611
(352) 392-3261
Principal Investigator: Javairiah Fatima, MD
University of Florida Gainesville UF has a long history of established programs in international education,...
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Gainesville, FL
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Los Angeles, California 90095
310-825-4321
Principal Investigator: William Quinones-Baldrich, MD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
Principal Investigator: Jean Panneton, MD
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Norfolk, VA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Cherrie Abraham, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Matthew Sweet, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Murray Shames, MD
University of South Florida The University of South Florida is a high-impact, global research university...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Himanshu Patel, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Austin, Texas 78756
Principal Investigator: Mark Felger, MD
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Baltimore, Maryland 21201
Principal Investigator: Robert Crawford, MD
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Buffalo, New York 14203
Principal Investigator: Maciej Dryjski, MD
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Joseph Lombardi, MD
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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Charlotte, North Carolina 28203
Principal Investigator: Frank Arko III, MD
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Charlottesville, Virginia 22908
Principal Investigator: John Kern, MD
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Andrew Hoel, MD
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Chicago, IL
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: G. Charles Huges, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, Texas 77030
Principal Investigator: Joseph Coselli, MD
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Houston, Texas 77030
Principal Investigator: Kristofer Charlton-Ouw, MD
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Indianapolis, Indiana 46290
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Indianapolis, IN
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1 Medical Center Drive
Lebanon, New Hampshire 03766
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Los Angeles, California 90033
Principal Investigator: Fernando Fleischman, MD
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Los Angeles, California 90048
Principal Investigator: Ali Azizzadeh, MD
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Louisville, Kentucky 40202
Principal Investigator: Kristen Sell-Dottin, MD
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Madison, Wisconsin 53792
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Memphis, Tennessee 38120
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Phoenix, Arizona 85006
Principal Investigator: Venkatesh Ramaiah, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Singh, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plano, Texas 75093
Principal Investigator: William Brinkman, MD
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Rochester, Minnesota 55905
Principal Investigator: Gustavo Oderich, MD
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Royal Oak, Michigan 48073
Principal Investigator: Alessandro Vivacqua, MD
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Luis A Sanchez, MD
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Stanford, California 94305
Principal Investigator: Michael Fischbein, MD
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Washington, District of Columbia
Principal Investigator: Edward Woo, MD
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