Actively Recruiting
Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
Led by Chandler Long, MD · Updated on 2026-02-04
30
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.
CONDITIONS
Official Title
Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have one or more of the following: an aneurysm larger than 5.5 cm or twice normal diameter near the aneurysm; aneurysm growth over 0.5 cm in 6 months; saccular aneurysm at high risk of rupture; symptomatic aneurysm; or ruptured aneurysm
- Aorta involvement including juxtarenal, pararenal (involving 1-2 renal arteries), paravisceral (including celiac or superior mesenteric arteries), or thoracoabdominal
- High risk for open surgery due to anatomic factors (such as previous abdominal or aortic surgeries) or physiologic factors (ASA Category III or higher, age over 70, heart conditions, congestive heart failure, or chronic obstructive pulmonary disease)
- Iliac or femoral artery suitable for vascular access with or without surgical conduit
- Non-aneurysmal aortic neck segment at least 25 mm long, with diameter between 18 mm and 42 mm, and angles less than 60 degrees relative to aneurysm and suprarenal aorta
- Branch vessel diameter greater than 5 mm
- Iliac artery distal fixation site longer than 20 mm with diameter between 9 mm and 21 mm
- Contralateral iliac artery distal fixation site longer than 20 mm with diameter between 7.5 mm and 20 mm
- Age 18 years or older
- Life expectancy greater than 2 years
You will not qualify if you...
- Able to be treated with a currently marketed endovascular prosthesis
- Unwilling to follow the study's follow-up schedule
- Unable or unwilling to give informed consent
- Pregnant or breastfeeding
- Prefers treatment at another hospital with non-physician-modified endovascular prosthesis access
- Refuses blood transfusions for religious or personal reasons
- Participating in another investigational study not related to this protocol within the past 30 days
- Has mycotic aneurysm or active systemic infection
- Known allergies or sensitivities to device materials including nitinol, polyester, polypropylene, gold, stainless steel, or solder
- Hypersensitivity or contraindication to anticoagulation or contrast media that cannot be managed
- Uncorrectable bleeding disorders
- Body size that prevents x-ray imaging or exceeds equipment limits, including morbid obesity (BMI 40 or BMI 30-39.9 with comorbidities)
- Major surgery unrelated to aneurysm planned within 30 days of repair
- Unstable angina or worsening chest pain
- Baseline creatinine level over 2.0 mg/dL
- History of connective tissue disorders like Marfan or Ehler's Danlos syndrome
- High risk due to serious comorbidities as defined by vascular surgery standards
- Significant thrombus or calcification in the aneurysm neck or seal zones
- Branch artery narrowing over 75% if untreated
- Anatomy that doesn't allow at least one hypogastric artery to remain open
- Inadequate femoral or iliac artery access for device delivery
- Need for iliac conduit due to poor access
- No suitable non-aneurysmal distal thoracic aorta segment or excessive aortic tortuosity
- Target vessels not compatible with stent graft placement due to size, shape, or narrowing
- Early vessel branching preventing safe stent placement
- Unsuitable iliac artery for limb extension or branch device placement per device instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
E
Ellen R Burkett, MSHS
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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