Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Recruiting N/A Interventional Study
Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Dissection
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
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About This Trial

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.

Trial Locations
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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 * Ao…
Contacts

Jessica Kelliher, BSN

617-632-7845

jjkellih@bilh.org

CONTACT