Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
Trial Parameters
Brief Summary
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.
Eligibility Criteria
INCLUSION CRITERIA: General inclusion criteria (applicable to all 3 study arms): * 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 * Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit * Non-aneurysmal aortic segment proximal to the aortic pathology with a: * Minimum neck length of 20 mm * Diameter between 20 - 42 mm * Non-aneurysm