NCT05195905 · Konstantinos Dean Arnaoutakis, MD
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
- Tampa, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2025 · Source of record for eligibility and locations