Zenith TX2® Post-market Approval Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | July 2009 |
| End Date: | October 2020 |
Zenith TX2® TAA Endovascular Graft Post-approval Study
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further
study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment
of thoracic aortic aneurysms.
study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment
of thoracic aortic aneurysms.
Inclusion Criteria:
- Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
- Descending thoracic aortic aneurysm with a history of growth greater than or equal to
0.5 cm within the previous 12 months; or
- Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or
equal to 10 mm in depth and 20 mm in diameter
Exclusion Criteria:
- Age less than 18 years
- Other medical condition that may cause the patient to be non-compliant with the
protocol, confound the results, or is associated with limited life expectancy (i.e.,
less than 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- Unwilling or unable to comply with the follow-up schedule
- Inability or refusal to give informed consent
- Simultaneously participating in another investigative device or drug study
We found this trial at
25
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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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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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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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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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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New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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