RecruitingNCT05004051
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
Sponsor
ViTAA Medical Solutions
Enrollment
200 participants
Start Date
Dec 15, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- Patient is aged 18 years or over
- Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
- Patient meets on-IFU criteria for endovascular reconstruction
Exclusion Criteria8
- 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.
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Interventions
DEVICEViTAA Analysis
Imaging Analysis Software
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05004051