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
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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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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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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