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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorViTAA Medical Solutions

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is aged 18 years or over

Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.

Patient meets on-IFU criteria for endovascular reconstruction

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ViTAA Analysis

    Device

    Imaging Analysis Software

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Patients who are booked for and then subsequently have undergone endovascular repair.1 intervention
Group B: Patients with infrarenal AA without indications for repair undergoing serial monitoring1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
1 year

Secondary outcomes

1

CHUM Ancillary Ultrasound Study

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

Time frame
6 months
2

CHUM Ancillary Ultrasound Study

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.