RECRUITING

PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

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Conditions

Pararenal Aortic AneurysmThoracoabdominal Aortic Aneurysm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-06
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05195905

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Male or female, aged ≥18 years
  3. 3. Expected survival beyond 1 year following successful aneurysm repair
  4. 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. 5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
  6. 6. Adequate proximal zone of fixation
  7. 7. Adequate distal zone of fixation
  8. 8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
  9. 9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary
  1. 1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
  2. 2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
  3. 3. Proximal landing within zone 0 or 1
  4. 4. Inability to maintain at least one patent hypogastric artery
  5. 5. Freely ruptured aneurysm with hemodynamic instability
  6. 6. Non-ambulatory status
  7. 7. Severe CHF
  8. 8. Baseline eGFR \< 30ml/min, unless currently on or to be initiating dialysis
  9. 9. Unstable angina
  10. 10. Stroke or MI within 3 months of planned treatment date
  11. 11. Active systemic infection and/or mycotic aneurysm
  12. 12. Uncorrectable coagulopathy or other bleeding diathesis
  13. 13. Known allergy to device material or contrast material that cannot be adequately pre-medicated
  14. 14. Body habitus that would preclude adequate fluoroscopic visualization of aorta
  15. 15. Pregnancy or lactation (confirmed per standard of care surgical practice)
  16. 16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair
  17. 17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
  18. 18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
  19. 19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
  20. 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

Contacts and Locations

Study Contact

Beth Montera
CONTACT
8138447948
bmontera@usf.edu
Konstantinos Arnaoutakis, MD
CONTACT
arnaoutakis@usf.edu

Principal Investigator

Konstantinos Arnaoutakis, MD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

Tampa General Hospital
Tampa, Florida, 33606
United States
University of South Florida - South Tampa Campus
Tampa, Florida, 33606
United States

Collaborators and Investigators

Sponsor: Konstantinos Dean Arnaoutakis, MD

  • Konstantinos Arnaoutakis, MD, PRINCIPAL_INVESTIGATOR, University of South Florida

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 Registration Dates

Study Start Date2023-06-06
Study Completion Date2029-08

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Pararenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm