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

Study Overview
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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.

Official Title
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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
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Other: ViTAA Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is aged 18 years or over Infrarenal Aortic Aneurysm ≥ 45 mm in diameter. Patient meets on-IFU criteria for endovascular reconstruction Exclusion Criteria: 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). Patient has a sensitivity to contrast imaging agents. Patient has aortic dissection. Patient has atrial fibrillation. Patient has arrhythmia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who are booked for and then subsequently have undergone endovascular repair.<br> | Other: ViTAA Analysis<br>* Imaging Analysis Software<br>|
| Patients with infrarenal AA without indications for repair undergoing serial monitoring<br> | Other: ViTAA Analysis<br>* Imaging Analysis Software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHUM Ancillary Ultrasound Study | For patients recruited at the CHUM: Correlation between ultrasound and multiphase CT based strain and RAW values Correlation between AAA growth and ultrasound-based strain and RAW maps | 6 months | 
| CHUM Ancillary Ultrasound Study | For patients recruited at the CHUM: Correlation between ultrasound and multiphase CT based strain and RAW values Correlation between AAA growth and ultrasound-based strain and RAW maps | 1 year |