Evaluation of the GORETM Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Purpose

To determine the safety and effectiveness of the GORETM Conformable TAG® Thoracic Endoprosthesis (the study device) when used to treat aneurysms of the descending thoracic aorta

Principal Investigator

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

For More Information Contact

Albina Underwood, RN (309) 672-4767
aunderwood@mmci.org

Summary

The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. Aneurysms are caused by weakening in the artery wall. Over time, this bulge may  continue to grow larger and rupture (break open). In this study, a device will be placed inside the aorta to protect the injured part of the artery wall. The materials used to make the study device are not investigational, but this device itself and its use in the treatment of thoracic descending aortic aneurysms are considered investigational. The study device is a modification of a device that is currently approved and available for sale in the United States. The study device is designed to have enhanced flexibility and resistance to compression.

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, 3 months, 6 months and annually for 5 years 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), a 4-view chest x-ray and CT scans (a thin beam of x-rays is focused on your abdomen to take a picture of your aneurysm).