ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for Abdominal Aortic Aneurysm
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.
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.
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.
Observational [Patient Registry]
Composite of aneurysm rupture or critical growth.
CHUM Ancillary Ultrasound Study
Abdominal Aortic Aneurysms
Study Arms / Comparison Groups
Patients who are booked for and then subsequently have undergone endovascular repair.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
December 15, 2021
December 31, 2023
Primary Completion Date
December 31, 2022
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.
18 Years - N/A
Accepts Healthy Volunteers
, 5145728673, [email protected]
ViTAA Medical Solutions