Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant.