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 |
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.
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
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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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University of South Florida The University of South Florida is a high-impact, global research university...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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