Thoracic Aortic Aneurysm, Penetrating Ulcers
Conditions
Keywords
Relay, Thoracic, Aneurysm
Brief summary
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
Interventions
Device implant
Sponsors
Bolton Medical
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer * Subjects whose anatomy can accommodate the Relay device * Subjects who consent to participate * Subjects who agree to a follow-up schedule
Exclusion criteria
* Subjects with lesions other than thoracic aneurysm and penetrating ulcer * Subjects with less than 1 year life expectancy * Subjects who are pregnant * Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease) * Subjects participating in another investigational study
Countries
United States
Outcome results
None listed