NCT05195905 PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
| NCT ID | NCT05195905 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Konstantinos Dean Arnaoutakis, MD |
| Condition | Pararenal Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-06-06 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Konstantinos Arnaoutakis, MD
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT05195905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pararenal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05195905 currently recruiting?
Yes, NCT05195905 is actively recruiting participants. Contact the research team at bmontera@usf.edu for enrollment information.
Where is the NCT05195905 trial being conducted?
This trial is being conducted at Tampa, United States, Tampa, United States.
Who is sponsoring the NCT05195905 clinical trial?
NCT05195905 is sponsored by Konstantinos Dean Arnaoutakis, MD. The principal investigator is Konstantinos Arnaoutakis, MD at University of South Florida. The trial plans to enroll 30 participants.