Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient is aged 18 years or over
• Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
• Patient meets on-IFU criteria for endovascular reconstruction
Locations
United States
Alabama
UAB - University of Alabama in Birmingham Hospital
RECRUITING
Birmingham
Massachusetts
MGH - Massachusetts General Hospital Fireman Vascular Center
RECRUITING
Boston
North Carolina
UNC - University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Canada
UCGY - University of Calgary, Peter Lougheed Center
RECRUITING
Calgary
CHUM - Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
MUHC - McGill University Health Centre
RECRUITING
Montreal
UHN - University Health Network - Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Denis Bilodeau
denisbilodeau@vitaamedical.com
5145728673
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Patients who are booked for and then subsequently have undergone endovascular repair.
Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)
Patients with infrarenal AA without indications for repair undergoing serial monitoring
Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program
Authors
Related Therapeutic Areas
Sponsors
Leads: ViTAA Medical Solutions