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

Last updated: September 15, 2025
Sponsor: ViTAA Medical Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular 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/dL or 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

    Site Not Available

  • UCGY - University of Calgary, Peter Lougheed Center

    Calgary 5913490, Alberta 5883102 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

    Site Not Available

  • UHN - University Health Network - Toronto General Hospital

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Active - Recruiting

  • CHUM - Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 3E4
    Canada

    Site Not Available

  • MUHC - McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • CHUM - Centre Hospitalier de l'Université de Montréal

    Montreal 6077243, Quebec 6115047 H2X 3E4
    Canada

    Active - Recruiting

  • MUHC - McGill University Health Centre

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

  • UAB - University of Alabama in Birmingham Hospital

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • UAB - University of Alabama in Birmingham Hospital

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • MGH - Massachusetts General Hospital Fireman Vascular Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • MGH - Massachusetts General Hospital Fireman Vascular Center

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • UNC - University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC - University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • University of Washington

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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