Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
Beth Israel Deaconess Medical Center
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.
Description
Complex aortic pathology, comprised of aneurysmal disease and aortic dissection involving the visceral aortic segment, presents a technical challenge for repair due to involvement of the renal and/or mesenteric arteries. Traditionally, the gold standard for repair has been open repair. However, open repair of these diseases is associated with high perioperative morbidity and mortality. Therefore, for patients with significant medical comorbidities or complex surgical/anatomical features, the risk of open surgery may be prohibitive. As endovascular techniques have become increasingly advanced,…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 cardiop…
Interventions
- DeviceEndovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
- DeviceTREO graft
Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts