Zenith TX2® Post-market Approval Study

Zenith TX2® TAA Endovascular Graft Post-approval Study

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.

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