RECRUITING

ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA

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Conditions

Abdominal Aortic Aneurysms

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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

This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using ViTAA (The Sponsor) aortic mapping technology.

Official Title

Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair

Quick Facts

Study Start:2021-12-15
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05004051

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. Patient is aged 18 years or over
  2. 2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
  3. 3. Patient meets on-IFU criteria for endovascular reconstruction
  1. 1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
  2. 2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
  3. 3. Patients with previous aortic reconstruction in the involved segment.
  4. 4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
  5. 5. Patient has a sensitivity to contrast imaging agents.
  6. 6. Patient has aortic dissection.
  7. 7. Patient has atrial fibrillation.
  8. 8. Patient has arrhythmia.

Contacts and Locations

Study Contact

Denis Bilodeau
CONTACT
5145728673
denisbilodeau@vitaamedical.com

Principal Investigator

Mark Farber
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

UAB - University of Alabama in Birmingham Hospital
Birmingham, Alabama, 35233
United States
MGH - Massachusetts General Hospital Fireman Vascular Center
Boston, Massachusetts, 02114
United States
UNC - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: ViTAA Medical Solutions

  • Mark Farber, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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 Date2021-12-15
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-12-15
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Abdominal Aortic Aneurysms