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NCT Number: NCT05004051

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCGY - University of Calgary, Peter Lougheed Center, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is aged 18 years or over
  • Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
  • Patient meets on-IFU criteria for endovascular reconstruction

Exclusion criteria

  • Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
  • Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
  • Patients with previous aortic reconstruction in the involved segment.
  • Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
  • Patient has a sensitivity to contrast imaging agents.
  • Patient has aortic dissection.
  • Patient has atrial fibrillation.
  • Patient has arrhythmia.

Treatment and study plan

ViTAA Analysis

Device

Imaging Analysis Software

Primary outcomes

  1. Composite of aneurysm rupture or critical growth.

    Time frame: 6 months

    • Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below
    • Critical growth defined as an increase of > 0.5 cm in aortic diameter.
    • Critical growth defined as an increase of > 0.5 cm in ILT.
    • Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.
  2. Composite of aneurysm rupture or critical growth.

    Time frame: 1 year

    • Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below
    • Critical growth defined as an increase of > 0.5 cm in aortic diameter.
    • Critical growth defined as an increase of > 0.5 cm in ILT.
    • Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.

Secondary outcomes

  1. CHUM Ancillary Ultrasound Study

    Time frame: 6 months

    For patients recruited at the CHUM:

    • Correlation between ultrasound and multiphase CT based strain and RAW values
    • Correlation between AAA growth and ultrasound-based strain and RAW maps
  2. CHUM Ancillary Ultrasound Study

    Time frame: 1 year

    For patients recruited at the CHUM:

    • Correlation between ultrasound and multiphase CT based strain and RAW values
    • Correlation between AAA growth and ultrasound-based strain and RAW maps

Study contacts

Contact information is provided by the study sponsor or research team.

Denis Bilodeau

CONTACT

[email protected]

5145728673

Sponsors and collaborators

Lead sponsor

ViTAA Medical Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2021
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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