Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
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|ClinicalTrials.gov Identifier: NCT00435942|
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : September 5, 2017
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers||Device: Relay Thoracic Stent-Graft Procedure: Open Repair||Not Applicable|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||May 15, 2017|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435942
|Principal Investigator:||Mark Farber, MD||University of North Carolina|