Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
ViTAA Medical Solutions
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DeviceViTAA Analysis
Imaging Analysis Software
Locations (8)
- UAB - University of Alabama in Birmingham HospitalBirmingham, Alabama
- MGH - Massachusetts General Hospital Fireman Vascular CenterBoston, Massachusetts
- UNC - University of North Carolina at Chapel HillChapel Hill, North Carolina
- University of WashingtonSeattle, Washington
- UCGY - University of Calgary, Peter Lougheed CenterCalgary, Alberta
- UHN - University Health Network - Toronto General HospitalToronto, Ontario