Early Feasibility Assessment of the Gore® Excluder® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels (GORE TAMBE)
ID Number 15-1382Principal Investigator(s)
Rami O Tadros
Department(s) or Division(s)
The purpose of this study is to assess the basic safety and functionality of the TAMBE Device to treat aortic aneurysms involving visceral branch vessels. The TAMBE device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. An aneurysm is a bulge in the aorta caused by a weakening in the artery wall. In this case, the aneurysm involves some or all of the visceral branch vessels, which are major blood vessels of your abdomen. Over time, an aneurysm may continue to grow and rupture (break open). In this research study, the TAMBE Device will be placed inside the aorta to protect the artery wall from rupture and still allow blood flow to the rest of the body. A unique feature of the TAMBE Device is its side branch components which allow treatment of aneurysms involving the large visceral branch vessels coming off of the aorta into the abdomen.
Patients may qualify to take part in this research study if they have an aortic aneurysm involving the visceral branch blood vessels that requires treatment.
Recruiting Patients: Yes