Actively Recruiting
Physician Modified Endovascular Grafts
Led by University of Washington · Updated on 2026-01-12
500
Participants Needed
1
Research Sites
2287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.
CONDITIONS
Official Title
Physician Modified Endovascular Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is over 18 years of age
- Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment)
- Patient or legally authorized representative has signed an Institutional Review Board approved informed consent form
- Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following: aneurysm larger than 5.5 cm, aneurysm growth of 0.5 cm in last 6 months, or maximum diameter exceeds 1.5 times adjacent normal aortic segment
- Patient has suitable iliac/femoral artery anatomy for endovascular access with or without a conduit
- Patient has a non-aneurysmal proximal aortic neck length greater than 2 mm below the lowest renal artery
- Patient has a non-aneurysmal distal iliac artery length (seal zone) greater than 15 mm preserving at least one hypogastric artery
- Patient has a non-aneurysmal proximal aortic neck diameter between 20 and 32 mm
- Patient has non-aneurysmal distal common iliac diameters between 8 and 20 mm
- Patient has juxtarenal aortic neck angulation less than 60 degrees
- Patient is willing to comply with all required follow-up exams
You will not qualify if you...
- Patient has a mycotic aneurysm or active systemic infection
- Patient has unstable angina with worsening or new symptoms
- Patient has a major surgical or interventional procedure planned within 30 days before or after the repair
- Patient has a history of connective tissue disease such as Marfan's or Ehler's-Danlos syndrome
- Patient has known allergy or contraindication to anticoagulation, contrast media, stainless steel, or gold that cannot be treated
- Patient has body habitus that prevents X-ray visualization of the aorta
- Patient has a life expectancy less than one year
- Patient is participating in another investigational device or drug clinical trial
- Patient has medical, social, or psychological conditions preventing required treatment and evaluations
- Patient is eligible for enrollment in a manufacturer-sponsored investigational device exemption at the site
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
A
Allison Larimore, MSN, RN
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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