Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases (Gore Thoracic)
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|ClinicalTrials.gov Identifier: NCT00546312|
Recruitment Status : Unknown
Verified May 2009 by Arizona Heart Institute.
Recruitment status was: Active, not recruiting
First Posted : October 18, 2007
Last Update Posted : May 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Descending Thoracic Aortic Disease||Device: Thoracic EXCLUDER Endoprosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||332 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases|
|Study Start Date :||February 2000|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
- Device: Thoracic EXCLUDER Endoprosthesis
Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
- Technical success [ Time Frame: following procedure ]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 ]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 ]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.
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): NCT00546312
|United States, Arizona|
|Arizona Heart Institute|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Edward B Diethrich, M.D.||Arizona Heart Institute|