TAG
Why is this study being done?
The main purpose of this study is to collect data about the long-term performance of the GORE TAG Thoracic Endoprosthesis through 5 years when used as the primary treatment of descending thoracic aneurysms. The TAG device has been tested in the United States and Europe and was approved by the FDA on March 23, 2005 for use in the primary treatment of descending thoracic aneurysms. As a condition of approval of the TAG device, the FDA required the sponsor (W.L. Gore & Associates) to evaluate and collect data on 150 subjects with thoracic aneurysms at up to 35 geographically dispersed sites.
The Study Device is commercially available in the United States and Europe. Neither the Study Device nor any of the medical procedures or evaluations done as part of the Research Study are experimental.
Who will participate in this study?
Approximately 10 people will take part in this study at Beth Israel Deaconess Medical Center. A total of 150 people will take part in this study at all study sites.
