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)



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 2023
Contact:Nick Pirooz, MHA
Email:npriooz@wlgore.com
Phone:623-234-5519

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
40
sites
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
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,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Cambria, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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,...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
Principal Investigator: Jean Panneton, MD
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tampa, FL 33612Bus: -
Tampa, Florida 33612
Principal Investigator: Murray Shames, MD
?
mi
from
Tampa, FL
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Himashu Patel, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78756
Principal Investigator: Mark Felger, MD
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
Principal Investigator: Robert Crawford, MD
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Buffalo, New York 14203
Principal Investigator: Maciej Dryjski, MD
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
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...
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Charlotte, North Carolina 28203
Principal Investigator: Frank Arko III, MD
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: John Kern, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Andrew Hoel, MD
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: G. Charles Hughes, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Joseph Coselli, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Fernando Fleischman, MD
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90048
Principal Investigator: Ali Azizzadeh, MD
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: Kristen Sell-Dottin, MD
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
Memphis, Tennessee 38120
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Phoenix, Arizona 85006
Principal Investigator: Venkatesh Ramaiah, MD
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: William Brinkman, MD
?
mi
from
Plano, TX
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Gustavo Oderich, MD
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Luis A Sanchez, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Stanford, California 94305
Principal Investigator: Michael Fischbein, MD
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Washington, District of Columbia 20010
Principal Investigator: Edward Woo, MD
?
mi
from
Washington,
Click here to add this to my saved trials