ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ViTAA Analysis.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device ViTAA Analysis
Imaging Analysis Software
Primary outcome measures
- Composite of aneurysm rupture or critical growth. [Time frame: 6 months]
- Composite of aneurysm rupture or critical growth. [Time frame: 1 year]
Secondary outcome measures (2)
- CHUM Ancillary Ultrasound Study [Time frame: 6 months]
- CHUM Ancillary Ultrasound Study [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patient is aged 18 years or over
- Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
- Patient meets on-IFU criteria for endovascular reconstruction
Exclusion criteria
- 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).
- Patient has a sensitivity to contrast imaging agents.
- Patient has aortic dissection.
- Patient has atrial fibrillation.
- Patient has arrhythmia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- UAB - University of Alabama in Birmingham Hospital — Birmingham
- MGH - Massachusetts General Hospital Fireman Vascular Center — Boston
- UNC - University of North Carolina at Chapel Hill — Chapel Hill
- University of Washington — Seattle
Canada · 4 centers
- UCGY - University of Calgary, Peter Lougheed Center — Calgary
- UHN - University Health Network - Toronto General Hospital — Toronto
- CHUM - Centre Hospitalier de l'Université de Montréal — Montreal
- MUHC - McGill University Health Centre — Montreal
Identifiers
NCT: NCT05004051 · CIP-ViTAA-001