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 indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.
Inclusion Criteria:
- 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 Criteria:
- 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
Last updated: 03/16/2013
NCT ID: NCT01151020
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