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

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.

Conditions

Abdominal Aortic Aneurysms

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Abdominal Aortic Aneurysms
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB - University of Alabama in Birmingham Hospital, Birmingham, Alabama, United States, 35233

Boston

MGH - Massachusetts General Hospital Fireman Vascular Center, Boston, Massachusetts, United States, 02114

Chapel Hill

UNC - University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27514

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ViTAA Medical Solutions,

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

Study Record Dates

2026-12-31