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

Recruiting

• Conditions: Abdominal Aortic Aneurysms

• Registration Number: NCT05004051
• Lead Sponsor: ViTAA Medical Solutions

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.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-13
• Study Start: 2021-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of aneurysm rupture or critical growth.	1 year	* 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 Outcome Measures

Name	Time	Method
CHUM Ancillary Ultrasound Study	1 year	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

Trial Locations

Locations (7)

UAB - University of Alabama in Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States

MGH - Massachusetts General Hospital Fireman Vascular Center; 🇺🇸 Boston, Massachusetts, United States

UNC - University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

UCGY - University of Calgary, Peter Lougheed Center; 🇨🇦 Calgary, Alberta, Canada

UHN - University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

CHUM - Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada

MUHC - McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada