Recruiting

Aortic Mapping

Sponsor:

ViTAA Medical Solutions

Code:

NCT05004051

Conditions

Abdominal Aortic Aneurysms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ViTAA Analysis

Study Details

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

Study ID

NCT05004051

Start date

Dec 15, 2021

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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

Interventions

ViTAA Analysis

Imaging Analysis Software

Primary outcome measure

  • Composite of aneurysm rupture or critical growth. [ Time Frame: 6 months ]
  • Composite of aneurysm rupture or critical growth. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

UAB - University of Alabama in Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Rebecca St John

rstjohn@uabmc.edu

Principal Investigator:

Adam Beck, MD

MGH - Massachusetts General Hospital Fireman Vascular Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jamie Attwood, RN

jlattwood@mgh.harvard.edu

Principal Investigator:

Matt Eagleton, MD

UNC - University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Principal Investigator:

Mark Farber, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Allison Larimore, MSN, RN, CCRN

206-744-8257alari@uw.edu

Principal Investigator:

Benjamin Starnes, MD

UCGY - University of Calgary, Peter Lougheed Center

Recruiting

Calgary, Alberta, Canada, T1Y 6J4

Contacts

Principal Investigator:

Paul Petrasek, MD

UHN - University Health Network - Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Naomi Eisenberg

Naomi.Eisenberg@uhn.ca

Principal Investigator:

Thomas Forbes, MD

CHUM - Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Principal Investigator:

Gilles Soulez, MD

MUHC - McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Principal Investigator:

Kent MacKenzie, MD

More Information

Sponsor

ViTAA Medical Solutions

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ViTAA Medical Solutions on 2025-09-19.