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

ViTAA Medical Solutions

Status: Enrolling

Conditions: Abdominal Aortic Aneurysms

Treatments: Device: ViTAA Analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT05004051

CIP-ViTAA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Patients who are booked for and then subsequently have undergone endovascular repair.

Description:

Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)

Treatment:

Device: ViTAA Analysis

Patients with infrarenal AA without indications for repair undergoing serial monitoring

Description:

Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program

Treatment:

Device: ViTAA Analysis