Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases (Gore Thoracic)
Recruitment status was Active, not recruiting
The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases|
- Technical success [ Time Frame: following procedure ] [ Designated as safety issue: Yes ]Successful completion of the treatment at the initial time of the procedure defined by successful access to the arterial system, deployment, placement and patency of the Thoracic TAG Endoprosthesis at time of procedure.
- Treatment Success [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Initial technical success and exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, defined as the absence of aneurysm enlargement (if aneurysm present) and avoidance of rupture, without major complications within 30 days of the procedure.
- Clinical Success [ Time Frame: through 12 months ] [ Designated as safety issue: Yes ]Treatment success followed by patency of the graft, and continued exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, without reintervention, rupture, and any major complications through twelve months.
|Study Start Date:||February 2000|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Device: Thoracic EXCLUDER Endoprosthesis
|United States, Arizona|
|Arizona Heart Institute|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Edward B Diethrich, M.D.||Arizona Heart Institute|