Using modified endografts to treat complex aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Orlando Health Wiregrass Ranch Hospital
  Wesley Chapel, Florida, United States Recruiting

Study contacts

• Principal investigator: Konstantinos Dean Arnaoutakis, MD — Orlando Health - Florida Medical Clinic
• Study coordinator: Janelle Barrera, MPH
• Email: janelle.barreraikan@orlandohealth.com
• Phone: 813-802-3781

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• BAO-G technique for repairing complex thoracoabdominal and abdominal aortic aneurysms

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• Evaluation of a 3D-Printed Stent-Graft for Aortic Aneurysms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.