PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Inclusion 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 implantedto obtain adequate sealing zone length

5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronicdissection

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 withdiameters between 4-12mm

9. Adequate arterial access for delivery system; use of iliac conduit is permitted asnecessary

Exclusion Criteria:

1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity

2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform aconduit

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 adequatelypre-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 clinicaldrug/device trial

18. Social or psychological issues that would interfere with ability to comply with allstudy procedures for the duration of the study

19. Can be treated in accordance with the instructions for use with a legally marketedendovascular device, including a manufacturer-fabricated custom device

20. Can enroll in a manufacturer-sponsored clinical study at our institution or iswilling and eligible to participate in a study with a manufacturer-made device atanother institution