Actively Recruiting
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Led by University of Alabama at Birmingham · Updated on 2026-01-06
410
Participants Needed
1
Research Sites
695 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
C
Cook Group Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.
CONDITIONS
Official Title
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Juxtarenal, suprarenal, or thoracoabdominal aortic pathology in stable patients including intact or contained ruptured aortic or aortoiliac aneurysms involving or near visceral aorta segments
- Aneurysm diameter over 5.5 cm if asymptomatic, or over 5.0 cm with growth over 0.5 cm in 6 months; any size if ruptured or symptomatic
- History of aneurysm growth over 0.5 cm per year
- Penetrating aortic ulcer over 2.0 cm depth or any size if ruptured or symptomatic
- Subacute (>14 days) or chronic (>20 days) aortic dissection with aneurysmal degeneration meeting specific size criteria
- Aortic arch pathology including aneurysm, pseudoaneurysm, type A dissection, retrograde type A dissection without aortic valve involvement, or penetrating ulcer with or without hematoma
- Suitable iliac and brachial artery access for device delivery
- Absence of severe landing zone angulation (>90 degrees) preventing device delivery or fixation
- Target arteries for arch branches with diameter under 24 mm and adequate landing zones
- Proximal and distal aortic fixation zones meeting size and length requirements
- Supra-aortic trunk vessels (innominate, carotid, subclavian) with specified diameters and sealing lengths
- Access for aortic dissection repair including true lumen from groin and supra-aortic trunk vessel
- True lumen size sufficient for device deployment and branch access
You will not qualify if you...
- Under 18 years of age
- Life expectancy less than 12 months
- Pregnant, breastfeeding, or planning pregnancy within 60 months
- Unable or unwilling to give informed consent
- Unable or unwilling to comply with follow-up schedule
- Participation in other investigational drug or device study within 30 days of primary endpoint
- Allergy to device materials such as stainless steel, polyester, solder, gold, or nitinol
- History of severe allergic reaction to contrast that cannot be treated
- Systemic or local infection increasing graft infection risk
- Poor kidney function with eGFR under 30 mL/min unless on dialysis
- Body habitus preventing X-ray visualization of the aorta
- Major unrelated surgery planned within 30 days of repair
- Unstable angina or irreversible coagulopathy
- Acute traumatic aortic transection
- Infectious aortic disease
- Significant vessel disease or anatomy preventing device delivery
- Proximal or distal landing zones too short or outside size limits
- Untreatable branch vessel stenosis or anatomy preventing graft placement
- Unsuitable aortic arch anatomy including neck size and landing zones
- Qualification for other industry-sponsored studies with similar repair
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
A
Adam W Beck, MD
CONTACT
R
Rebecca St John
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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