Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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:

8/20/2014

NCT ID:

NCT01151020

IRB Number:

10-004191