Zenith® TX2® Low Profile TAA Endovascular Graft



Status:Approved for marketing
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019

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Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory
safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated
for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer
and has an anatomy suitable for repair.


Inclusion Criteria:

- Meets one of the following

- Descending thoracic aneurysm with diameter ≥ 5.0 cm

- Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year

- Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20
mm in diameter

Exclusion Criteria:

- Life expectancy less than 2 years

- Pregnant of breastfeeding or planning on becoming pregnant within 60 months

- Unwilling to comply with the follow-up schedule

- Less than 30 days beyond primary endpoint for other investigative drug or device study

- Receiving home oxygen

- Myocardial infarction within the last 3 months

- Stroke within the last 3 months

- Diagnosed or suspected congenital degenerative collagen disease

- Systemic infection

- Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion

- Allergy to polyester, polypropylene, nitinol, or gold

- Previous placement of a thoracic endovascular graft

- Prior open repair involving the descending thoracic aorta
We found this trial at
15
sites
Indianapolis, Indiana 46202
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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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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Philadelphia, PA
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Ann Arbor, MI
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
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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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Indianapolis, Indiana 46250
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Indianapolis, IN
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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...
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Lebanon, NH
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New York, New York 10029
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New York, NY
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63110
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Saint Louis, MO
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