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

April 6, 2024 updated by: Dr Mark Farber, ViTAA Medical Solutions

Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • UHN - University Health Network - Toronto General Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Forbes, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM - Centre Hospitalier de l'Universite de Montreal
        • Principal Investigator:
          • Gilles Soulez, MD
        • Contact:
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • MUHC - McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Kent MacKenzie, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • UAB - University of Alabama in Birmingham Hospital
        • Contact:
        • Principal Investigator:
          • Adam Beck, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • MGH - Massachusetts General Hospital Fireman Vascular Center
        • Contact:
        • Principal Investigator:
          • Matt Eagleton, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC - University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Mark Farber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who are booked for and then subsequently have undergone endovascular repair.
Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)
Device: ViTAA Analysis
Imaging Analysis Software
Patients with infrarenal AA without indications for repair undergoing serial monitoring
Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program
Device: ViTAA Analysis
Imaging Analysis Software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of aneurysm rupture or critical growth.
Time Frame: 6 months
  • 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
Composite of aneurysm rupture or critical growth.
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHUM Ancillary Ultrasound Study
Time Frame: 6 months

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
6 months
CHUM Ancillary Ultrasound Study
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViTAA Medical Solutions

Investigators

  • Principal Investigator: Mark Farber, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-ViTAA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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