Status:
COMPLETED
TX2® Low Profile TAA Endovascular Graft
Lead Sponsor:
Cook Research Incorporated
Conditions:
Aortic Aneurysm
Penetrating Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicat...
Eligibility Criteria
Inclusion
- Descending thoracic aneurysm with diameter ≥ 5.0 cm
- Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
- Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
Exclusion
- Less than 18 years of age
- Life expectancy less than 2 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent
- Less than 30 days beyond primary endpoint for other investigative drug or device study
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01151020
Start Date
March 1 2010
End Date
May 11 2018
Last Update
January 22 2021
Active Locations (33)
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1
Kaiser Permanente
San Francisco, California, United States, 94115
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
University of South Florida
Tampa, Florida, United States, 33606
4
Emory University
Atlanta, Georgia, United States, 30322