PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Recruiting now · Not applicable

Conditions studied: Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT05195905

Run by

Konstantinos Dean Arnaoutakis, MD

People needed

30

Starts

2023-06-06

Expected to finish

2029-08-01

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Male or female, aged ≥18 years
• Expected survival beyond 1 year following successful aneurysm repair
• 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
• Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
• Adequate proximal zone of fixation
• Adequate distal zone of fixation
• No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
• Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary

You may not qualify if…

• Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
• Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
• Proximal landing within zone 0 or 1
• Inability to maintain at least one patent hypogastric artery
• Freely ruptured aneurysm with hemodynamic instability
• Non-ambulatory status
• Severe CHF
• Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis
• Unstable angina
• Stroke or MI within 3 months of planned treatment date
• Active systemic infection and/or mycotic aneurysm
• Uncorrectable coagulopathy or other bleeding diathesis
• Known allergy to device material or contrast material that cannot be adequately pre-medicated
• Body habitus that would preclude adequate fluoroscopic visualization of aorta
• Pregnancy or lactation (confirmed per standard of care surgical practice)
• Major, unrelated surgical procedure planned ≤30 days from endovascular repair
• Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
• Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
• Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
• 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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.