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

Abdominal Aortic Aneurysms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004051
• Other study ID #: CIP-ViTAA-001
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: ViTAA Medical Solutions
• Contact: Denis Bilodeau
• Phone: 5145728673
• Email: denisbilodeau[@]vitaamedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• ViTAA Analysis
Imaging Analysis Software

Locations

Country	Name	City	State
Canada	UCGY - University of Calgary, Peter Lougheed Center	Calgary	Alberta
Canada	CHUM - Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	MUHC - McGill University Health Centre	Montréal	Quebec
Canada	UHN - University Health Network - Toronto General Hospital	Toronto	Ontario
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
ViTAA Medical Solutions

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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