The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.
Aortic pathology that fits one of the study arms (see below for detailed description)
Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option
Estimated perioperative risk is lower than the estimated 1-year mortality without surgery
Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Subject is unwilling to comply with the follow-up schedule