PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Konstantinos Dean Arnaoutakis, MD

Status: Enrolling

Conditions: Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Device: PMEG

Study type: Interventional

Funder types: Other

Identifiers

NCT05195905

STUDY002613

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Physician-modified endografts

Experimental group

Description:

For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

Treatment:

Device: PMEG