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NCT05004051Recruiting

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

ViTAA Medical Solutions

Start Date

12/15/2021

Completion Date

12/31/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

ViTAA Analysis

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Conditions

Abdominal Aortic Aneurysms

Locations

UAB - University of Alabama in Birmingham Hospital

Birmingham, Alabama 35233

United States

MGH - Massachusetts General Hospital Fireman Vascular Center

Boston, Massachusetts 02114

United States

UNC - University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

University of Washington

Seattle, Washington 98104

United States

UCGY - University of Calgary, Peter Lougheed Center

Calgary, Alberta T1Y 6J4

Canada

UHN - University Health Network - Toronto General Hospital

Toronto, Ontario M5G 2C4

Canada

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec H2X 3E4

Canada

MUHC - McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada