PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Launched by KONSTANTINOS DEAN ARNAOUTAKIS, MD · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with specific types of aortic aneurysms, known as pararenal and thoracoabdominal aortic aneurysms. The goal is to assess the safety and effectiveness of specially modified devices, called endografts, that are designed by surgeons. This treatment is intended for patients who cannot undergo traditional surgery due to other health issues or who have a body structure that makes standard devices unsuitable.

To participate in this trial, individuals must be at least 18 years old and expected to live for more than a year after the procedure. They should have an aneurysm that requires special care, but they should not have certain serious health problems, like severe heart failure or major infections. Participants can expect to receive close monitoring during the trial to ensure their safety and to evaluate how well the treatment works. This study is currently looking for participants, and it offers a potential new option for those with complicated aortic conditions.

Gender

ALL

Eligibility criteria

• 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 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
• Exclusion Criteria:
• • 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