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.
Study Type
OBSERVATIONAL
Enrollment
150
Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.
Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.
Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.
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.
Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.
The University Clinical Centre
Gdansk, Poland
The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, Poland
Świętokrzyskie Cardiology Center, Regional Combined Hospital in Kielce
Kielce, Poland
The John Paul II Specialist Hospital in Kraków
Krakow, Poland
University Hospital in Kraków
Krakow, Poland
The Cardinal Stefan Wyszyński National Institute of Cardiology
Warsaw, Poland
The 4th Military Teaching Hospital
Wroclaw, Poland
The Jan Mikulicz-Radecki University Teaching Hospital
Wroclaw, Poland
Diagnostic accuracy (AUC ROC) of the Cardiolens® Platform for detecting coronary stenoses eligible for prognostic revascularization (>10% ischemia)
Assessment of diagnostic accuracy (AUC ROC) of the Cardiolens® Platform for identifying vessels with functionally significant stenosis requiring prognostic revascularization (\>10% ischemia), using ICA + FFR + CTP as the reference standard. Per-vessel, intention-to-diagnose analysis. Unit of measure: AUC ROC (0-1 scale) Measurement tools: Cardiolens® Platform vs reference: ICA + FFR (≤0.80) + CTP (\>10% ischemia)
Time frame: Up to 18 months
Sensitivity, specificity, PPV, NPV, and accuracy of the Cardiolens® Platform for detecting functionally significant stenoses
Evaluation of diagnostic parameters (sensitivity, specificity, PPV, NPV, and overall accuracy) of the Cardiolens® Platform in detecting stenoses associated with \>10% ischemia. Unit of measure: % Measurement tools: Cardiolens® Platform vs ICA + FFR + CTP
Time frame: Up to 18 months
AUC ROC comparison between Cardiolens® Platform and standard imaging modalities for identifying arteries requiring revascularization
Comparison of AUC ROC values for Cardiolens® Platform versus each comparator modality listed above in predicting arteries that underwent clinically indicated revascularization. Unit of measure: AUC ROC (0-1 scale) Measurement tools: * CCTA, * CCTA + FFRCT, * CCTA + CTP, * CCTA + FFRCT + CTP, * CCTA + FFRCT with stenosis location (ESC high-risk segments), * ICA, * ICA + FFR, * ICA + iFR/RFR/dPR
Time frame: 18 months
Agreement between SYNTAX Score calculated from CCTA, functional SYNTAX Score from CCTA+FFRCT, and functional SYNTAX Score from CCTA+Cardiolens®, referenced to ICA+FFR
Correlation analysis between anatomical and functional SYNTAX scores obtained from several imaging modalities compared to the reference standard (ICA+FFR). Unit of measure: correlation coefficient (r) Measurement tools: SYNTAX score algorithms on CCTA, FFRCT, Cardiolens® vs ICA+FFR
Time frame: 18 months
Diagnostic accuracy of the Cardiolens® Platform on a per-patient level
Unit: % accuracy, sensitivity, specificity, PPV, NPV Measurement tool: Cardiolens® Platform vs ICA + FFR + CTP
Time frame: 18 months
Diagnostic accuracy of the Cardiolens® Platform for predicting performed coronary revascularization (per-patient)
Unit: % accuracy, sensitivity, specificity, PPV, NPV Measurement tool: Cardiolens® Platform vs actual revascularization decisions
Time frame: 18 months
Diagnostic accuracy of the Cardiolens® Platform for predicting performed coronary revascularization (per-vessel)
Unit: % accuracy, sensitivity, specificity, PPV, NPV Measurement tool: Cardiolens® Platform vs actual revascularization decisions
Time frame: 18 months
Exploratory accuracy of the Cardiolens® Platform for detecting coronary microvascular dysfunction
Unit: correlation coefficient (r) or AUC ROC (specify based on your protocol) Measurement tool: Cardiolens® microvascular perfusion vs reference standard (specify - e.g., CTP, IMR, CFR)
Time frame: 18 months
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