Actively Recruiting
Physician Modified Endograft For Complex Aortic Aneurysm Repair
Led by University of California, Davis · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
CONDITIONS
Official Title
Physician Modified Endograft For Complex Aortic Aneurysm Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is > 18 years of age
- Male or non-pregnant female (females of childbearing potential must have a negative pregnancy test before enrollment)
- Able and willing to sign an IRB-approved informed consent form
- Has a complex, juxtarenal, pararenal, or thoracoabdominal aortic aneurysm with at least one of the following: diameter 2 5.5 cm, growth 2 0.5 cm in the last 6 months, or symptomatic aneurysm
- Cannot be treated with currently approved non-modified devices
- High risk for open surgical repair due to anatomic or physiologic factors, including previous surgeries, age over 70, heart or lung conditions
- Has patent iliac or femoral arteries suitable for endovascular access or an iliac conduit
- Has a suitable non-aneurysmal proximal aortic neck length 2 20 mm
- Has a suitable non-aneurysmal distal iliac artery length 2 15 mm
- Repair preserves at least one hypogastric artery
- Has a suitable proximal aortic neck diameter between 15 and 42 mm
- Has suitable distal common iliac diameters between 7 and 20 mm
You will not qualify if you...
- Has a mycotic aneurysm
- Has a ruptured aneurysm requiring urgent or emergency repair
- Has a systemic or local infection increasing graft infection risk
- Has body habitus preventing X-ray visualization of the aorta
- Is participating in another manufacturer-sponsored clinical study elsewhere
- Has a major surgical or interventional procedure planned within 30 days before or after aneurysm repair
- Currently participating in another investigational device or drug trial
- Has known hypersensitivity or contraindication to anticoagulation or contrast media not treatable
- Allergic or intolerant to stainless steel, polyester, polypropylene, nickel, titanium, or gold
- Has uncorrectable coagulopathy
- Has unstable angina or progressive chest pain symptoms
- History of connective tissue disease such as Marfan's or Ehler's-Danlos syndrome
- Active malignancy with life expectancy under 2 years
- Limited life expectancy under 2 years
- Has other medical, social, or psychological conditions precluding treatment or follow-up
- Significant occlusive disease, tortuosity, or calcification preventing endovascular access
- Proximal seal site with circumferential thrombus or atheroma
- Unable to maintain at least one patent hypogastric artery
- Has shaggy aorta
- Not suitable for temporary or permanent open surgical or endovascular conduit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
Research Team
S
Sina Zarrintan, MD
CONTACT
K
Kathleen Groh
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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