N/A
Completed N=115
Zenith TX2® Post-market Approval Study
Descending Thoracic Aortic Aneurysm
Source: ClinicalTrials.gov NCT00813358 ↗
Enrolled (actual)
115
Serious AEs
72.2%
Results posted
May 2021
Primary outcomePrimary: Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality — 114 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality |
114 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00813358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.