Actively Recruiting
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Led by Konstantinos Dean Arnaoutakis, MD · Updated on 2025-04-16
30
Participants Needed
2
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
CONDITIONS
Official Title
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female aged 18 years or older
- Expected survival beyond 1 year after successful aneurysm repair
- Anatomy requiring coverage of celiac artery, superior mesenteric artery, and/or renal arteries for adequate sealing
- Thoracoabdominal or pararenal aortic aneurysm with or without chronic dissection
- Adequate proximal and distal zones of fixation
- No more than 5 non-aneurysmal visceral arteries (celiac, SMA, or renal) with diameters 4-12 mm
- Adequate arterial access for delivery system; iliac conduit allowed if needed
You will not qualify if you...
- Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
- Severe iliac stenosis, calcification, or tortuosity without ability to perform a conduit
- Proximal landing zone within 0 or 1
- Inability to maintain at least one patent hypogastric artery
- Freely ruptured aneurysm with hemodynamic instability
- Non-ambulatory status
- Severe congestive heart failure
- Baseline eGFR less than 30 ml/min unless on or starting dialysis
- Unstable angina
- Stroke or myocardial infarction within 3 months before planned treatment
- Active systemic infection or mycotic aneurysm
- Uncorrectable coagulopathy or bleeding disorder
- Known allergy to device or contrast material not controllable by pre-medication
- Body habitus preventing adequate fluoroscopic visualization of aorta
- Pregnancy or lactation
- Major unrelated surgery planned within 30 days of repair
- Participation in another investigational clinical trial beyond 30 days from primary endpoint
- Social or psychological issues interfering with study compliance
- Can be treated with legally marketed endovascular device or enroll in manufacturer-sponsored study elsewhere
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
2
University of South Florida - South Tampa Campus
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
B
Beth Montera
CONTACT
K
Konstantinos Arnaoutakis, MD
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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