Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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