Using modified endografts to treat complex aortic aneurysms

Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts

This study tests if specially modified stents can safely treat people with complex aortic aneurysms who can't have regular surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Locations: 2 sites (Tampa, Florida and 1 other locations)
• Trial ID: NCT05195905 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of surgeon-modified endografts for patients with pararenal and thoracoabdominal aortic aneurysms who cannot undergo traditional open repair due to anatomical challenges or comorbidities. The approach involves customizing endografts to accommodate specific anatomical requirements, particularly when standard FDA-approved options are unsuitable. The study aims to provide a viable treatment alternative for patients with complex aortic pathology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific anatomical conditions that prevent the use of standard endografts.

Not a fit: Patients with severe aortic neck calcification, tortuosity, or those who cannot achieve adequate arterial access may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a less invasive treatment option for patients with complex aortic aneurysms, potentially improving survival and quality of life.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using modified endografts for complex aortic conditions.

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

Where this trial is running

Tampa, Florida and 1 other locations

• Tampa General Hospital — Tampa, Florida, United States (Recruiting)
• University of South Florida - South Tampa Campus — Tampa, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Konstantinos Arnaoutakis, MD — University of South Florida
• Study coordinator: Beth Montera

Conditions Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm