Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs) (NCT04746677)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (35 items) and avoid the listed exclusions (19 items).
Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- EXCLUSION CRITERIA: General Exclusion Criteria
- Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Subject is unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by subject or legal representative
- Subject is pregnant or breastfeeding
- Subject has a ruptured aneurysm Arm 5 • Patient meets criteria for Arms 1-4 \- Patient is undergoing repair using the TREO bifurcated stent graft Indications for using TREO bifurcated stent graft:
- Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR
- -Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \< 115 mm; OR
- In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR
- Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha/Alpha 2 endograft. Medical Exclusion Criteria
- Known sensitivities or allergies to the materials of construction of the devices
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.