About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is aged 18 years or over
Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
Patient meets on-IFU criteria for endovascular reconstruction
Disqualifiers
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).
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
ViTAA Analysis
DeviceImaging Analysis Software
Treatment groups
Trial 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.
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.
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
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
Sponsors and contacts
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