Clinical trial NCT05004051: ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
Official title: Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysms
Lead sponsor: ViTAA Medical Solutions
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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: 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.

Primary outcomes:
measure: Composite of aneurysm rupture or critical growth.
timeFrame: 6 months
measure: Composite of aneurysm rupture or critical growth.
timeFrame: 1 year
Secondary outcomes:
measure: CHUM Ancillary Ultrasound Study
timeFrame: 6 months
measure: CHUM Ancillary Ultrasound Study
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB - University of Alabama in Birmingham Hospital
state: Alabama
city: Boston
country: United States
facility: MGH - Massachusetts General Hospital Fireman Vascular Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: UNC - University of North Carolina at Chapel Hill
state: North Carolina
city: Calgary
country: Canada
facility: UCGY - University of Calgary, Peter Lougheed Center
state: Alberta
city: Toronto
country: Canada
facility: UHN - University Health Network - Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: MUHC - McGill University Health Centre
state: Quebec
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Farber
role: PRINCIPAL_INVESTIGATOR
References: