Trials / Approved For Marketing
Approved For MarketingNCT01327742
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Bolton Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Relay Thoracic Stent-Graft | Device implant |
Timeline
- First posted
- 2011-04-04
- Last updated
- 2012-11-19
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01327742. Inclusion in this directory is not an endorsement.