Actively Recruiting
Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Led by Bjoern D. Suckow · Updated on 2026-04-15
80
Participants Needed
1
Research Sites
350 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
Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 50 years of age or older at the time of informed consent
- Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that does not extend above the left subclavian artery
- Must have an aneurysm size meeting standard surgical repair criteria (6.0 cm in descending thoracic aorta or 5.5 cm in abdominal aorta)
- Must be considered a high-risk candidate for open surgical repair by the investigator
- Must commit to comply with the five-year study follow-up schedule
- Must have a non-aneurysm-related life expectancy greater than 2 years
- Must have an aneurysm necessitating coverage of one or more visceral vessels for seal
- Must be able to provide informed consent
You will not qualify if you...
- Aneurysm caused by acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection
- Ruptured or acutely symptomatic aortic aneurysm
- Known connective tissue disorder
- Imaging shows lack of adequate non-aneurysmal proximal or distal seal zones
- Branch vessel targets smaller than 5 mm or larger than 10 mm in diameter
- Untreated left subclavian artery stenosis or occlusion
- Untreated hypogastric artery occlusion
- Indispensable inferior mesenteric artery
- Untreatable branching, duplication, aneurysm, or stenosis of visceral arteries preventing device implantation
- Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
- History of anaphylaxis to contrast dye without proper prophylaxis
- Uncorrectable bleeding disorders
- Unstable angina
- Body habitus preventing X-ray visualization of the aorta
- Major unrelated surgery planned within 30 days of repair
- Participation in other clinical studies affecting this device
- Contraindications to oral antiplatelet therapy
- Prisoners or those under alternative sentencing
- Known systemic infection risking graft infection
- Need for MRI within 3 months after device insertion
- Candidate for repair with FDA-approved commercial endovascular graft
- Eligible for participation in manufacturer-sponsored clinical studies at this or other institutions
- Other conditions judged by the investigator to exclude participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
A
Amirsadreddin Kazzazi
CONTACT
C
Caren Saunders
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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