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Recruiting NCT05004051

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

Trial Parameters

Condition Abdominal Aortic Aneurysms
Sponsor ViTAA Medical Solutions
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-12-15
Completion 2026-12-31
Interventions
ViTAA Analysis

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.

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.

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