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To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety and
Efficacy study
Official Title: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of
Thoracic Aortic Diseases for Non-Surgical Candidates under the Physician Sponsored IDE.
PURPOSE OF RESEARCH:
You are invited to participate in a research study for treatment of aneurysms of the
descending thoracic aorta. The investigational device, called the TAG Thoracic
Endoprosthesis (device) has been designed to simplify treatment of aneurysms of the
descending thoracic aorta. The other pathologies treated can include pseudoaneurysms, acute
and chronic dissections, penetrating ulcers, mycotic aneurysms, ruptures, fistulae, and
transections.The device is made from a graft (an artificial vessel) which is surrounded on
the outside by a metal mesh-like form. The device is in the shape of a tube. The device
reinforces the weakened part of the aorta from the inside. Blood flows through the device to
the arteries that go to your abdomen and legs. The device is folded tightly onto a catheter
(a flexible, hollow tube) that is put into the aorta through an artery in your leg. Unless
there is a problem, you would not need to have your chest opened.