GORE TAG Clinical Trial

A Clinical Evaluation of the GORE TAG® Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Purpose:

To assess the long-term performance of the GORE TAG®Thoracic device (the study device) through five years when used as the primary treatment of thoracic aneurysms.

Principal Investigator:

James Williams, MD, FACS, FCCP, FACC
Cardiac, Thoracic and Endovascular Therapies

For More Information Contact:

Tracy Rennie, MPH, RN
(309) 672-4808
tlrennie@mmci.org

Summary:

Patients with an aortic aneurysm in their chest may be eligible to participate in this trial. The GORE TAG®Thoracic Endoprosthesis (the study device) was approved by the US Food and Drug Administration (FDA) in 2005. The study device has been tested in the United States and Europe. It has been approved by the FDA for use in the primary treatment of descending thoracic aneurysms. Neither the study device nor any of the medical procedures or tests done as part of this research study is experimental. Information about the patient's medical history, aneurysm and procedure will be collected for the study. There will be follow-up appointments with the study doctor at 30 days, 1 year and annually to see how you are doing. Blood will be drawn for laboratory tests. Other tests that will be performed include an angiogram (a catheter-based test that provides detailed images of the heart and blood vessels) and CT scans (a thin beam of x-rays is focused on your abdomen to take a picture of your aneurysm). The study is expected to last 60 months.