Evaluation of the Performance of the Cardiolens® Platform, Which Utilizes a Non-Invasive Combined Anatomical and Functional CCTA-based Assessment in Patients With Suspected CCS

A prospective, confirmatory, multicenter, open-label clinical investigation of a Class IIa medical device (in accordance with Article 62 of Regulation 2017/745), conducted to confirm the performance of the Cardiolens® Platform, which is based on a non-invasive, combined anatomical and functional assessment (intention-to-diagnose) using CCTA in patients with suspected chronic coronary syndrome (CCS). The introduction of the new diagnostic method - the Cardiolens® Platform - will benefit enrolled patients by reducing the number of diagnostic procedures, including invasive procedures, that currently provide equivalent diagnostic information for the identification of significant coronary stenoses qualifying for prognostic revascularization (i.e., those causing large areas of ischemia). Virtual simulations and results generated by the Cardiolens® Platform will be compared with reference data from standard procedures performed in each participant and with actual clinical decisions made based on routine diagnostic methods. Therefore, no control group has been deemed necessary for this study. Additionally, simulations related to the assessment (results) of FFRCT and MBF-CT obtained using the Cardiolens® Platform will be blinded with respect to participant data and randomly assigned to investigators for final evaluation of ischemia significance.

NCT Number	NCT07472634
Lead Sponsor	Hemolens Diagnostics Sp. z o.o. Collaborators: KCRI
Conditions	Chronic Coronary Syndrome
Enrollment	150 participants
Start Date	2023-10-18
Primary Completion	2025-06-26 (estimated)
Study Completion	2025-07-04 (estimated)
Updated on ClinicalTrials.gov	2026-03-18