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Evaluation of the GORE EXCLUDER thoracoabdominal branch endoprosthesis in the treatment of thoracoabdominal and pararenal aortic aneurysms clinical trial

photo of Dr. Raghu Motaganahalli

Indiana University School of Medicine's, Department of Surgery, Vascular Surgery Division, along with their Cardiac Surgery colleagues will be participating in a pivotal trial to determine the safety and effectiveness of a modular device designed to be the first off-the-shelf option for endovascular repair of thoracoabdominal aortic aneurysms involving the visceral branch vessels. This pivotal trial, Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE) uses a novel endovascular device manufactured by W.L Gore & Associates for treatment of complex thoracoabdominal aortic aneurysms.

The TAMBE clinical trial, led by Principal Investigator Raghu Motaganahalli, MD, Associate Professor of Surgery, and Division Chief of Vascular Surgery at IU School of Medicine along with co-investigators Joel Corvera, MD, Associate Professor of Clinical Surgery, and Director for Thoracic Aortic Program, Andres Fajardo, MD, Associate Professor of Clinical Surgery, Alan Sawchuk, MD, Professor of Surgery, Alok Gupta, MD, Assistant Professor of Clinical Surgery, and John Maijub, MD, Assistant Professor of Surgery, will provide this novel treatment option for patients in Indiana.

Endovascular devices such as TAMBE provide an alternative to traditional open surgical procedures and offers an off-the-shelf solution that would eliminate the wait time of several weeks currently required to for a custom manufactured device. Results from this pivotal study could lead to FDA approval for the TAMBE device and the ability to offer prompt endovascular repair as an alternative to the risks and longer post-operative recovery associated with open repair.

Endovascular repair of thoracoabdominal aneurysms requires advanced technical skill and is offered in a limited number of aortic endovascular centers. Indiana University Methodist Hospital is the only designated site in Indiana for the TAMBE clinical trial providing novel endovascular solutions to complex thoracoabdominal aortic aneurysms. The TAMBE clinical trial marks yet another achievement for the IU Health Methodist Vascular Surgery Program. The IU Health Vascular Surgery Team have long supported research efforts to advance the new technology and bring innovative vascular therapies to patients in Indiana.

If you need more information on the study, you may contact the Division of Vascular Surgery Research Nurse, Janet Klein at 317-962-0287.

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