Zenith TX2® Post-market Approval Study
- Conditions
- Descending Thoracic Aortic Aneurysm
- Registration Number
- NCT00813358
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality 5 years Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (25)
Kaiser Permanente
🇺🇸San Francisco, California, United States
University of Denver Colorado
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Heart Care Midwest
🇺🇸Peoria, Illinois, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Scroll for more (15 remaining)Kaiser Permanente🇺🇸San Francisco, California, United States