Thoracoabdominal aneurysm surgery.
E S Crawford, J S Coselli
https://pubmed.ncbi.nlm.nih.gov/1793767Actively Recruiting
Phase Not Applicable
Age: 50Years - 95Years
All Genders
ID02989948
Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)
Led by Yale University · Updated on 2026-04-27
80
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for treating thoracoabdominal aortic aneurysms (TAAAs). This study compares the use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft to previously published results of open surgical replacement of the aneurysmal aorta. The purpose is to demonstrate both safety and effectiveness in adult patients who meet traditional size criteria for surgical repair. The study includes two groups: one using the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for asymptomatic, non-ruptured TAAAs meeting traditional size criteria, and an expanded access group that also includes thoracic or abdominal aortic aneurysms with similar criteria. The device is used endovascularly to treat aneurysms of any Crawford extent (I-V). Patients are followed for five years after the procedure. Participants will undergo multiple assessments including survival rates, major adverse events, treatment and technical success at various time points up to five years. Monitoring includes evaluation of complications such as aneurysm rupture, access site issues, neurological events, and conversion to open repair. The study collects data on treatment outcomes and safety, with follow-up visits scheduled for up to five years post-procedure.
CONDITIONS
Brief Title
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Who Can Participate
Age: 50Years - 95Years
All Genders
Eligibility Criteria
You may qualify if you...
- Men or women 50 years of age or older at consent
- Have a thoracoabdominal aortic aneurysm of any Crawford classification (I-V) extending no more proximal than the left subclavian artery
- Aneurysm size meets standard surgical repair indications (6.0 cm descending thoracic or 5.5 cm abdominal aorta)
- Considered high risk for open surgical repair by the investigator
- Not eligible for commercially available FDA-approved endovascular graft repair
- Able to provide informed consent
- Able to comply with five-year study assessment schedule
- Non-aneurysm-related life expectancy greater than 2 years as judged by the investigator
You will not qualify if you...
- Aneurysm caused by dissection, intramural hematoma, penetrating ulcer, pseudoaneurysm, mycotic aneurysm, or trauma
- Ruptured or acutely symptomatic aneurysm
- Known connective tissue disorder
- Imaging shows inadequate proximal or distal seal zones
- Branch vessel diameters outside specified ranges
- Untreated left subclavian artery stenosis or occlusion
- Untreated hypogastric artery occlusion
- Essential inferior mesenteric artery
- Vessel abnormalities preventing device implantation
- Allergies to device materials (stainless steel, PTFE, polyester, polypropylene, nitinol, gold)
- History of anaphylaxis to contrast with inability to prevent reaction
- Uncorrectable blood clotting disorders
- Unstable angina
- Body habitus interfering with X-ray visualization
- Major unrelated surgery planned within 30 days of repair
- Participation in other clinical studies affecting device performance
- Known or suspected pregnancy
- Contraindication to oral antiplatelet therapy
- Prisoners or under alternative sentencing
- Known systemic infections risking graft infection
- Need for MRI within 3 months after device insertion
- Other conditions deemed exclusionary by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of surgery
Participants receive a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft to treat thoracoabdominal aortic aneurysms.
1 surgical procedure
Post-operative Follow-up
Duration - 5 years
Participants are monitored for safety and effectiveness of the graft with regular assessments.
Visits at 30 days; 6 months; and annually up to 5 years
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
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Research Team
D
David P. Kuwayama, M.D., MPA
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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Published Research Related To This Trial
Spinal cord protection in descending thoracic and thoracoabdominal aortic repair.
H J Safi, C C Miller
https://pubmed.ncbi.nlm.nih.gov/10391343The natural history of thoracic aortic aneurysms.
O E Dapunt, J D Galla, A M Sadeghi...
https://pubmed.ncbi.nlm.nih.gov/8176976Natural history of thoracic aortic aneurysms.
Gregory A Kuzmik, Adam X Sang, John A Elefteriades
https://pubmed.ncbi.nlm.nih.gov/22840907Improved prognosis of thoracic aortic aneurysms: a population-based study.
W D Clouse, J W Hallett, H V Schaff...
https://pubmed.ncbi.nlm.nih.gov/9851478Epidemiology of aortic aneurysm repair in the United States from 1993 to 2003.
John A Cowan, Justin B Dimick, Peter K Henke...
https://pubmed.ncbi.nlm.nih.gov/17182917Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.
Adrian O'Callaghan, Tara M Mastracci, Matthew J Eagleton
https://pubmed.ncbi.nlm.nih.gov/25449006Comparison of fenestrated endografts and the snorkel/chimney technique.
Jason T Lee, George K Lee, Venita Chandra...
https://pubmed.ncbi.nlm.nih.gov/24785682Branched endografts for thoracoabdominal aneurysms.
Roy Greenberg, Matthew Eagleton, Tara Mastracci
https://pubmed.ncbi.nlm.nih.gov/21092788Contemporary analysis of descending thoracic and thoracoabdominal aneurysm repair: a comparison of endovascular and open techniques.
Roy K Greenberg, Qingsheng Lu, Eric E Roselli...
https://pubmed.ncbi.nlm.nih.gov/18678769