Actively Recruiting
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Led by Baylor College of Medicine · Updated on 2026-01-20
760
Participants Needed
3
Research Sites
948 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
W
William Cook Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
CONDITIONS
Official Title
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thoracoabdominal aortic aneurysm with diameter 5.5 cm or more or twice the normal aortic diameter
- Aneurysm showing growth of 0.5 cm or more per year
- Saccular aneurysms considered at high risk for rupture by a physician
- Concomitant thoracoabdominal and aortic arch aneurysm meeting above criteria
- Thoracoabdominal aortic aneurysm with unilateral or bilateral common iliac artery aneurysm 3.0 cm or larger or saccular morphology without suitable landing zone proximal to iliac bifurcation
You will not qualify if you...
- Under 18 years of age
- Unwillingness to follow the study's follow-up schedule
- Inability or refusal to give informed consent
- Pregnant or breastfeeding
- Life expectancy less than 2 years
- Open surgical or interventional procedure within 30 days before the study, except planned staged procedures for access or to aid repair
- Participation in other investigational clinical or device trials except certain stent-graft or medical therapy studies
- Ruptured aortic aneurysms needing urgent repair, except stable contained ruptures suitable for off-the-shelf design
- Allergies to device materials like stainless steel, polyester, or contrast agents
- Leaking or ruptured aneurysms with low blood pressure
- Uncorrectable blood clotting disorders
- Active systemic infection or mycotic aneurysm
- Connective tissue disorders affecting vascular repair except specified cases
- Body size preventing X-ray visualization of the aorta
- Inadequate femoral or iliac artery access or inability to perform surgical or endovascular conduit
- Unsuitable aortic or visceral vessel anatomy for device placement
- Unsuitable distal iliac artery anatomy for device fixation
- Specific anatomical criteria for aortic arch device use including vessel diameter, length, and sealing zones
- Criteria regarding aortic dissection anatomy and access
- Iliac anatomy must allow delivery of the arch branch device in a 20F-24F sheath
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
3
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77089
Active, Not Recruiting
Research Team
A
Andrea C Martinez, MS
CONTACT
Y
Ying Huang, MD, PhD
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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