Actively Recruiting
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-08
220
Participants Needed
1
Research Sites
524 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have an aortic problem that fits one of the study groups (complex abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, or aortic dissection)
- Aortic problem not treatable with FDA-approved commercial devices or unsafe to wait for a custom device
- High risk for complications with open surgery due to heart/lung function, other diseases, or anatomy
- Compatible iliac or femoral artery access for vascular devices
- Non-aneurysmal aortic segment near the problem with minimum neck length of 20 mm and diameter between 20-42 mm
- Distal aortic or iliac segment with fixation site longer than 20 mm (aortic) or 10 mm (iliac), with specified diameter ranges
- Age 21 years or older
- Expected to live at least 2 more years
- Specific detailed criteria for each study arm about aneurysm size, growth, symptoms, prior repairs, or dissection details
You will not qualify if you...
- Eligible for enrollment in a manufacturer-sponsored investigational device study
- Unable or unwilling to follow the study's follow-up schedule
- Unable or refuses to give informed consent
- Pregnant or breastfeeding
- Has a ruptured aneurysm
- Known allergies to device materials
- Allergic or contraindicated to anticoagulation or contrast media that cannot be managed
- Uncorrectable bleeding disorders
- Body size or shape prevents safe imaging
- Active infections increasing graft infection risk
- Diagnosed connective tissue disorders like Marfan or Ehler's Danlos syndrome
- Unable to have iliac conduit for access if needed
- Excessive clot or calcium buildup in aneurysm neck
- Visceral artery anatomy not suitable for modified graft placement due to disease or small size
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jessica Kelliher, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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