Zenith TX2® Post-market Approval Study
- Conditions
- Descending Thoracic Aortic Aneurysm
- Interventions
- Device: Zenith TX2® TAA Endovascular Graft
- 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
- Arm && Interventions
Group Intervention Description Endovascular repair Zenith TX2® TAA Endovascular Graft treatment
- 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
Trial Locations
- Locations (25)
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center at Dallas
🇺🇸Dallas, Texas, United States
New York University
🇺🇸New York, New York, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
DFW Vascular Group
🇺🇸Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Denver Colorado
🇺🇸Aurora, Colorado, United States
Heart Care Midwest
🇺🇸Peoria, Illinois, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
New York Hospital of Queens
🇺🇸Flushing, New York, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States