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

Last updated: April 6, 2024
Sponsor: ViTAA Medical Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Cardiovascular Disease

Heart Disease

Treatment

ViTAA Analysis

Clinical Study ID

NCT05004051
CIP-ViTAA-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion 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

Exclusion

Exclusion Criteria:

  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/dLor 175umol/L
  3. Patients with previous aortic reconstruction in the involved segment.
  4. Patients receiving oral or parenteral corticosteroid therapy for other unrelateddisease. (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.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: ViTAA Analysis
Phase:
Study Start date:
December 15, 2021
Estimated Completion Date:
December 31, 2026

Study Description

This a prospective, multi-center, registry of patients that are being assessed with the ViTAA software. Patients will be enrolled at selected North American centers in the US and Canada. The Registry will enroll patients from the following two populations:

  • patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair (EVAR);

  • patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program.

Connect with a study center

  • UCGY - University of Calgary, Peter Lougheed Center

    Calgary, Alberta T1Y 6J4
    Canada

    Active - Recruiting

  • HSC - Health Sciences Centre

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • UHN - University Health Network - Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • CHUM - Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • MUHC - McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • UAB - University of Alabama in Birmingham Hospital

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • MGH - Massachusetts General Hospital Fireman Vascular Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • UNC - University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.