PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

April 14, 2025 updated by: Konstantinos Dean Arnaoutakis, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Konstantinos Arnaoutakis, MD
        • Contact:
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida - South Tampa Campus
        • Principal Investigator:
          • Konstantinos Arnaoutakis, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physician-modified endografts
For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.
Device: PMEG
All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with 30-day major adverse events from primary procedure
Time Frame: Day 30
Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc
Day 30
Number of subjects with treatment success
Time Frame: Month 12
Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with mortality, major adverse events, spinal cord ischemia
Time Frame: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60
Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia.
Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60
Number of subjects with treatment success and freedom from secondary intervention
Time Frame: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60
Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication.
Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konstantinos Dean Arnaoutakis, MD

Investigators

  • Principal Investigator: Konstantinos Arnaoutakis, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY002613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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