Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic
 stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the
 device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft)
 through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in
 subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair.
 Long term follow-up is conducted through 5 years.
Inclusion Criteria:

 -  Subjects with diagnosed descending thoracic aortic aneurysms or penetrating
 atherosclerotic ulcers

 -  Subjects who are at least 18 years of age

 -  Subjects whose anatomy can accommodate the Relay device

 -  Subjects who consent to participate

 -  Subjects who agree to comply with follow-up schedule

 Exclusion Criteria:

 -  Subjects with non-aneurysm lesions

 -  Subjects with less than 1 year life expectancy

 -  Subjects who are pregnant

 -  Subjects with medical conditions that would complicate the endovascular procedure or
 confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta,
 severe coronary artery disease, morbid obesity, etc.)

 -  Subjects participating in another investigational study