Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
NCT04746677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-04-08
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.
Conditions
- Abdominal Aortic Aneurysm
- Thoracoabdominal Aortic Aneurysm
- Aortic Dissection
Interventions
- DEVICE
-
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
- DEVICE
-
TREO graft
Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-15
- Primary Completion
- 2031-03-31
- Completion
- 2031-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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