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

NCT ID: NCT05004051

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

ViTAA Analysis

Intervention Type DEVICE

Imaging Analysis Software

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

ViTAA Analysis

Intervention Type DEVICE

Imaging Analysis Software

Interventions

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ViTAA Analysis

Imaging Analysis Software

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViTAA Medical Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr Mark Farber

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Farber

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UAB - University of Alabama in Birmingham Hospital

Birmingham, Alabama, United States

Site Status RECRUITING

MGH - Massachusetts General Hospital Fireman Vascular Center

Boston, Massachusetts, United States

Site Status RECRUITING

UNC - University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

UCGY - University of Calgary, Peter Lougheed Center

Calgary, Alberta, Canada

Site Status RECRUITING

UHN - University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

MUHC - McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Denis Bilodeau

Role: CONTACT

5145728673

Facility Contacts

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Rebecca St John

Role: primary

Jamie Attwood, RN

Role: primary

Rebekah Roten

Role: primary

Allison Larimore, MSN, RN, CCRN

Role: primary

206-744-8257

Sonja Katt

Role: backup

206-744-8257

Emi Sanders

Role: primary

Naomi Eisenberg

Role: primary

Jennifer Satterthwaite

Role: primary

514 890-8000 ext. 23483

Casey Bourdeau-Caporuscio, BSc, MSc

Role: backup

514-890-8000 ext. 14756

Marie-Amélie Lukaszewski

Role: primary

+1 514-934-1934 ext. 35113

Other Identifiers

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CIP-ViTAA-001

Identifier Type: -

Identifier Source: org_study_id

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