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

Brief Title

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

Official Title

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.

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 Type

Observational [Patient Registry]

Primary Outcome

Composite of aneurysm rupture or critical growth.

Secondary Outcome

 CHUM Ancillary Ultrasound Study

Condition

Abdominal Aortic Aneurysms

Intervention

ViTAA Analysis

Study Arms / Comparison Groups

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

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

December 15, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 5145728673, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT05004051

Organization ID

CIP-ViTAA-001

Responsible Party

Principal Investigator

Study Sponsor

ViTAA Medical Solutions

Study Sponsor

, ,

Verification Date

February 2022