NCT07472634

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

Ocena wartości Diagnostycznej Cardiolens® Platform zawierającej Produkty FFR-CT Pro i Perfusion, służącej Kompleksowej, Nieinwazyjnej Anatomiczno - czynnościowej Diagnostyce Choroby wieńcowej

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Hemolens Diagnostics Sp. z o.o. · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	CCTA (Coronary Computed Tomography Angiography)	Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.
PROCEDURE	ICA (Invasive Coronary Angiography)	Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.
PROCEDURE	FFR (Fractional Flow Reserve)	Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.
DEVICE	CNBP measurement	Per the protocol, patients will have the measurement of the resting Continuous Non-Invasive Blood Pressure (CNBP). The signal is required for iSIL-FFR technology.
DEVICE	Cardiolens Platform	Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-06-26
• Completion: 2025-07-04
• First posted: 2026-03-16
• Last updated: 2026-03-18

Locations

8 sites across 1 country: Poland

Regulatory

• FDA-regulated device study