This trial is active, not recruiting.

Condition descending thoracic aortic aneurysm
Treatment zenith tx2® taa endovascular graft
Sponsor Cook
Start date July 2009
End date October 2020
Trial size 115 participants
Trial identifier NCT00813358, 08-005, 370024, 2PAS


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
zenith tx2® taa endovascular graft TEVAR
Endovascular treatment with the study device

Primary Outcomes

Thoracic aortic aneurysm-related mortality
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Zenith TX2® TAA Endovascular Graft Post-approval Study
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Cook.