Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysms
- Sponsor
- ViTAA Medical Solutions
- Enrollment
- 200
- Locations
- 8
- Primary Endpoint
- Composite of aneurysm rupture or critical growth.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
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.
Investigators
Dr Mark Farber
Principal Investigator
ViTAA Medical Solutions
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.
Outcomes
Primary Outcomes
Composite of aneurysm rupture or critical growth.
Time Frame: 1 year
* Critical growth defined as an increase of \> 0.5 cm in any of the three growth measurements below * Critical growth defined as an increase of \> 0.5 cm in aortic diameter. * Critical growth defined as an increase of \> 0.5 cm in ILT. * Critical growth defined as an increase of \> 0.5 cm in aneurysm sac volume.
Secondary Outcomes
- CHUM Ancillary Ultrasound Study(1 year)