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

NCT05004051 | Recruiting FDA Device

• 1 other identifier: CIP-ViTAA-001
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Abdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (2)

• Composite of aneurysm rupture or critical growth.

  * 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.

  6 months

• Composite of aneurysm rupture or critical growth.

  * 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.

  1 year

Secondary Outcomes (2)

• CHUM Ancillary Ultrasound Study

  6 months

• CHUM Ancillary Ultrasound Study

  1 year

Study Arms (2)

Patients who are booked for and then subsequently have undergone endovascular repair.

Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)

Device: ViTAA Analysis

Patients with infrarenal AA without indications for repair undergoing serial monitoring

Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program

Device: ViTAA Analysis

Interventions

ViTAA Analysis DEVICE

Imaging Analysis Software

Patients who are booked for and then subsequently have undergone endovascular repair.; Patients with infrarenal AA without indications for repair undergoing serial monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients who are booked for and then subsequently have undergone endovascular repair. 2. Patients with infrarenal aortic aneurysms without indications for repair undergoing serial monitoring.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViTAA Medical Solutions: lead

Study Sites (8)

UAB - University of Alabama in Birmingham Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

MGH - Massachusetts General Hospital Fireman Vascular Center

Boston, Massachusetts, 02114, United States

RECRUITING

UNC - University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

UCGY - University of Calgary, Peter Lougheed Center

Calgary, Alberta, T1Y 6J4, Canada

RECRUITING

UHN - University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MUHC - McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Mark Farber

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Bilodeau

CONTACT

5145728673; denisbilodeau@vitaamedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 13, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CA (4); US (4)