Clinical Trials

TX2® Low Profile TAA Endovascular Graft

Location:

Rochester,  MN

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: 03/16/2013

NCT ID:

NCT01151020