Status:
RECRUITING
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Lead Sponsor:
Konstantinos Dean Arnaoutakis, MD
Conditions:
Pararenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Male or female, aged ≥18 years
- Expected survival beyond 1 year following successful aneurysm repair
- Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
- Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
- Adequate proximal zone of fixation
- Adequate distal zone of fixation
- No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
- Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary
Exclusion
- Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
- Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
- Proximal landing within zone 0 or 1
- Inability to maintain at least one patent hypogastric artery
- Freely ruptured aneurysm with hemodynamic instability
- Non-ambulatory status
- Severe CHF
- Baseline eGFR \< 30ml/min, unless currently on or to be initiating dialysis
- Unstable angina
- Stroke or MI within 3 months of planned treatment date
- Active systemic infection and/or mycotic aneurysm
- Uncorrectable coagulopathy or other bleeding diathesis
- Known allergy to device material or contrast material that cannot be adequately pre-medicated
- Body habitus that would preclude adequate fluoroscopic visualization of aorta
- Pregnancy or lactation (confirmed per standard of care surgical practice)
- Major, unrelated surgical procedure planned ≤30 days from endovascular repair
- Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
- Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
- Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
- Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
Key Trial Info
Start Date :
June 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05195905
Start Date
June 6 2023
End Date
August 1 2029
Last Update
April 16 2025
Active Locations (2)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606
2
University of South Florida - South Tampa Campus
Tampa, Florida, United States, 33606