Actively Recruiting
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Led by Yale University · Updated on 2026-04-27
80
Participants Needed
2
Research Sites
610 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
CONDITIONS
Official Title
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 50 years or older at the time of consent
- Thoracoabdominal aortic aneurysm of any Crawford classification (I-V) extending no more proximal than the left subclavian artery
- Aneurysm size meeting standard surgical repair criteria (6.0 cm descending thoracic aorta or 5.5 cm abdominal aorta)
- Considered high risk for open surgical repair by the study investigator
- Not eligible for repair using FDA-approved commercial endovascular grafts
- Able to provide informed consent
- Able to comply with the five-year study schedule
- Expected to live more than 2 years unrelated to aneurysm, per investigator judgment
You will not qualify if you...
- Aneurysm caused by acute or chronic dissection, intramural hematoma, penetrating ulcer, pseudoaneurysm, mycotic aneurysm, or trauma
- Ruptured or acutely symptomatic aneurysm
- Known connective tissue disorders
- Imaging showing inadequate proximal or distal seal zones or unsuitable branch vessel sizes
- Untreated left subclavian artery stenosis or occlusion
- Untreated unilateral or bilateral hypogastric artery occlusion
- Indispensable inferior mesenteric artery
- Branching, duplication, aneurysm, or untreatable stenosis of key arteries preventing device implantation
- Allergies to device materials like stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
- History of severe allergic reaction to contrast dye without proper prophylaxis
- Uncorrectable bleeding disorders
- Unstable angina
- Body size preventing clear X-ray imaging of the aorta
- Planned major surgery unrelated to aneurysm within 30 days of repair
- Participation in other clinical studies affecting this device
- Known or suspected pregnancy
- Contraindication to oral antiplatelet therapy
- Prisoners or those under alternative sentencing
- Systemic infection risking graft infection
- Expected need for MRI within 3 months of device insertion
- Other investigator-judged conditions or comorbidities excluding participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Active, Not Recruiting
Research Team
D
David P. Kuwayama, M.D., MPA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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