ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
NCT ID: NCT05004051
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-12-15
2026-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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
ViTAA Analysis
Imaging Analysis Software
Interventions
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ViTAA Analysis
Imaging Analysis Software
Eligibility Criteria
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Inclusion Criteria
2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
3. Patient meets on-IFU criteria for endovascular reconstruction
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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ViTAA Medical Solutions
INDUSTRY
Responsible Party
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Dr Mark Farber
Principal Investigator
Principal Investigators
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Mark Farber
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UAB - University of Alabama in Birmingham Hospital
Birmingham, Alabama, United States
MGH - Massachusetts General Hospital Fireman Vascular Center
Boston, Massachusetts, United States
UNC - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Washington
Seattle, Washington, United States
UCGY - University of Calgary, Peter Lougheed Center
Calgary, Alberta, Canada
UHN - University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
MUHC - McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP-ViTAA-001
Identifier Type: -
Identifier Source: org_study_id
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