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

ViTAA Medical Solutions200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Abdominal Aortic Aneurysms

Interventions

ViTAA AnalysisDEVICE

Imaging Analysis Software

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

UAB - University of Alabama in Birmingham Hospital

Birmingham, Alabama, United States

RECRUITING

MGH - Massachusetts General Hospital Fireman Vascular Center

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Composite of aneurysm rupture or critical growth.

Time frame: 1 year

Secondary Outcomes

CHUM Ancillary Ultrasound Study

For patients recruited at the CHUM: 1. Correlation between ultrasound and multiphase CT based strain and RAW values 2. Correlation between AAA growth and ultrasound-based strain and RAW maps

Time frame: 6 months

CHUM Ancillary Ultrasound Study

For patients recruited at the CHUM: 1. Correlation between ultrasound and multiphase CT based strain and RAW values 2. Correlation between AAA growth and ultrasound-based strain and RAW maps

Time frame: 1 year

Central Contacts

Denis Bilodeau

CONTACT

5145728673 denisbilodeau@vitaamedical.com

Data from ClinicalTrials.gov

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