N/A
Completed N=180
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Thoracic Aortic Aneurysms · and Penetrating Atherosclerotic Ulcers
Source: ClinicalTrials.gov NCT00435942 ↗
Enrolled (actual)
180
Serious AEs
62.8%
Results posted
Sep 2017
Primary outcomePrimary: Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects — 97 participants — p=>0.80
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects |
97 | >0.80 |
| PRIMARY Primary Safety Endpoint: Distribution of Major Adverse Events |
27; 51 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00435942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.