200
Participants
Start Date
January 31, 2025
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2025
Deep Learning-based Vulnerable Plaque Detection and Assessment Tool
"Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.~This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.~The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study."
Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia, Pavia
Lead Sponsor
Azienda Socio-Sanitaria Territoriale di Pavia
UNKNOWN
GE Healthcare
INDUSTRY