Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
|Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers||Device: Relay Thoracic Stent-Graft Procedure: Open Repair|
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|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies|
- Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects [ Time Frame: 1 year ]
The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.
The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
- Primary Safety Endpoint: Distribution of Major Adverse Events [ Time Frame: 1 year ]The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
|Study Start Date:||January 2007|
|Study Completion Date:||May 15, 2017|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Endovascular Treatment arm to be implanted with Relay device
Device: Relay Thoracic Stent-Graft
Active Comparator: 2
Surgical Control, underwent open repair
Procedure: Open Repair
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435942
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|Principal Investigator:||Mark Farber, MD||University of North Carolina|