Status:
COMPLETED
Zenith TX2® Post-market Approval Study
Lead Sponsor:
Cook Research Incorporated
Conditions:
Descending Thoracic Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00813358
Start Date
July 10 2009
End Date
March 23 2020
Last Update
June 4 2021
Active Locations (25)
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1
Kaiser Permanente
San Francisco, California, United States, 94115
2
University of Denver Colorado
Aurora, Colorado, United States, 80045
3
University of Florida
Gainesville, Florida, United States, 32610
4
Tampa General Hospital
Tampa, Florida, United States, 33601