To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) \> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Endovascular aortic stent-graft
University of Alabama Medical Center
Birmingham, Alabama, United States
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Time frame: Treatment through 1 month post treatment
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Time frame: Treatment through 1 month post procedure
Procedure Time (Minutes)
Total time in minutes required for surgical device implantation.
Time frame: Initial Device Implant Procedure During Index Hospitalization
Operative Blood Loss (mL)
Blood loss in mL during initial device implantation procedure
Time frame: Initial Device Implant Procedure During Index Hospitalization
Days of Convalescence Stay in an Intensive Care Unit
Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Time frame: During the Index Hospitalization
Total Length of Hospital Stay (Days)
Total days of hospital stay during the initial hospitalization for implantation of device
Time frame: Total Duration of the Index Hospitalization
Time in Days to Return to Normal Daily Activities
This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Time frame: Average time within one month window
Procedural Survival
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Subjects who survived the index procedure
Time frame: Initial Device Implant Procedure During Index Hospitalization
Intensive Care Unit (ICU) Stay
Subjects admitted to ICU during index hospitalization
Time frame: Initial Device Implant Index Hospitalization