PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

• 1. Provision of signed and dated informed consent form
• 2. Male or female, aged ≥18 years
• 3. Expected survival beyond 1 year following successful aneurysm repair
• 4. 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
• 5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
• 6. Adequate proximal zone of fixation
• 7. Adequate distal zone of fixation
• 8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
• 9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary
• 1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
• 2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
• 3. Proximal landing within zone 0 or 1
• 4. Inability to maintain at least one patent hypogastric artery
• 5. Freely ruptured aneurysm with hemodynamic instability
• 6. Non-ambulatory status
• 7. Severe CHF
• 8. Baseline eGFR \< 30ml/min, unless currently on or to be initiating dialysis
• 9. Unstable angina
• 10. Stroke or MI within 3 months of planned treatment date
• 11. Active systemic infection and/or mycotic aneurysm
• 12. Uncorrectable coagulopathy or other bleeding diathesis
• 13. Known allergy to device material or contrast material that cannot be adequately pre-medicated
• 14. Body habitus that would preclude adequate fluoroscopic visualization of aorta
• 15. Pregnancy or lactation (confirmed per standard of care surgical practice)
• 16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair
• 17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
• 18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
• 19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
• 20. 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