Actively Recruiting
Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
Led by Bolton Medical · Updated on 2026-02-18
20
Participants Needed
7
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System. The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm? Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
CONDITIONS
Official Title
Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of consent
- Life expectancy greater than 2 years
- Abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft with suitable anatomy confirmed by contrast CT within 6 months
- Male participants with aneurysm diameter 6 cm or female participants with diameter 5 cm, or aneurysm diameter exceeding twice the normal diameter proximal to the aneurysm, or saccular aneurysm needing treatment
- Aneurysm with documented growth over 0.5 cm in 6 months
- Juxtarenal aneurysm with at least 0 mm healthy aorta below the lowest renal artery and no renal artery involvement, or suprarenal aneurysm involving at least one renal artery with minimum 2 mm below the celiac artery
- Proximal landing zone with length 20 mm, diameter 20-32 mm, and angles 406 relative to suprarenal aorta axis and aneurysm long axis
- Distal iliac landing zone with 8-13 mm diameter and 10 mm length or >13-20 mm diameter and 15 mm length
- Distal aortic diameter above iliac bifurcation at least 70% of sum of iliac limb graft diameters
- Minimum 18 mm aortic lumen diameter at fenestration level
- A pathology requiring up to 5 fenestrations in the main body spaced at least 3 mm apart
- Branch vessels to be bridged with diameters 5-9 mm and distal landing zone 13 mm (or 15 mm if gap exists)
- Adequate renal function for contrast CT
- Adequate vascular access for delivery systems
- Willingness to comply with follow-up schedule and signed informed consent
You will not qualify if you...
- Pregnant or lactating individuals
- Existing endovascular graft in the treated segment planned for repair
- Dissection in abdominal aorta, ruptured or symptomatic aneurysm
- Planned implant procedure does not preserve at least one patent hypogastric artery unless both are occluded
- Branch vessels with dissection, significant calcification, tortuosity, or thrombus interfering with stent delivery or sealing
- Severe untreated coronary artery disease, unstable angina, left ventricular ejection fraction below 20%, or recent congestive heart failure
- Stroke or heart attack within 6 months before treatment
- Chronic obstructive pulmonary disease requiring routine oxygen therapy at home
- Chronic kidney disease stage 3b or higher (with exceptions in expanded access arm)
- Active or suspected systemic infection including AIDS/HIV or sepsis
- Conditions severely impairing x-ray visualization of the aorta
- History of aortopathic connective tissue disease such as Marfan's syndrome
- Mycotic aneurysm
- Significant or circumferential calcification or thrombus in proximal aortic neck, distal iliac landing zone, or treatment length
- Inability to receive required anticoagulation or antiplatelet therapy
- Blood clotting disorders that cannot be paused for treatment
- Recent investigational drug or device use that could interfere with study
- Medical, social, or psychological conditions interfering with treatment or follow-up
- Untreatable allergies to contrast media, device materials, or graft components
- Major surgery or medical interventions within 45 days before or planned within 45 days after implantation
AI-Screening
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Trial Site Locations
Total: 7 locations
1
UC Health Memorial
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
2
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Mt. Sinai
New York, New York, United States, 10019
Active, Not Recruiting
6
Baylor Scott and White Research Institute
Plano, Texas, United States, 75093
Active, Not Recruiting
7
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
L
Lauren Rider
CONTACT
V
Valerie Merkle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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