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Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01327742
First Posted: April 4, 2011
Last Update Posted: November 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bolton Medical
March 31, 2011
April 4, 2011
November 19, 2012
 
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
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.
Not Provided
Expanded Access
Device: Relay Thoracic Stent-Graft
Device implant
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01327742
Bolton Medical
Bolton Medical
Not Provided
Not Provided
Bolton Medical
November 2012