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

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 Overview

• Status: Completed
• Conditions: Chronic Coronary Syndrome
• Intervention / Treatment: Procedure: CCTA (Coronary Computed Tomography Angiography); Procedure: ICA (Invasive Coronary Angiography); Procedure: FFR (Fractional Flow Reserve); Device: CNBP measurement; Device: Cardiolens Platform

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland
    • The University Clinical Centre
  • Katowice, Poland
    • The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
  • Kielce, Poland
    • Świętokrzyskie Cardiology Center, Regional Combined Hospital in Kielce
  • Krakow, Poland
    • University Hospital in Krakow
  • Krakow, Poland
    • The John Paul II Specialist Hospital in Kraków
  • Warsaw, Poland
    • The Cardinal Stefan Wyszyński National Institute of Cardiology
  • Wroclaw, Poland
    • The 4th Military Teaching Hospital
  • Wroclaw, Poland
    • The Jan Mikulicz-Radecki University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Positive medical history suggestive of chronic coronary syndrome (CCS)

Description

Inclusion Criteria

1. Age 18-90 years.
2. Signed informed consent to participate in the study.
3. Positive medical history suggestive of chronic coronary syndrome (CCS).
4. Diagnostic CCTA performed no more than 122 days prior to the planned ICA, of sufficient quality to assess the entire coronary tree (both arteries reconstructable in a single series), demonstrating at least one ≥50% stenosis in an epicardial coronary artery >2.0 mm in diameter, not previously revascularized.
5. Planned ICA with the intention to perform FFR measurement no later than 122 days after the CCTA.
6. Stable treatment for CCS without the need for dose adjustments for at least 30 days prior to study inclusion.

Exclusion Criteria

1. Presence of myocardial bridging on CCTA causing >50% systolic narrowing of an epicardial coronary artery, per Investigator's assessment.
2. Complications occurring during CCTA that reduce the safety or feasibility of CTP (per treating physician decision).
3. Stenosis of the left main coronary artery >40%.
4. Myocardial infarction occurring between CCTA and ICA, documented by elevated cardiac biomarkers (troponin, myoglobin) or new wall motion abnormalities or new coronary occlusion.
5. History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the last 90 days. Not applicable to patients undergoing functional testing with regadenoson.
6. Atrioventricular block (type II-III), prolonged QT interval, or sick sinus syndrome.
7. Renal insufficiency (creatinine ≥1.6 and/or glomerular filtration rate <30 ml/m²) or renal failure requiring dialysis.
8. Persistent atrial fibrillation.
9. BMI >40.
10. Implanted pacemaker or internal cardioverter-defibrillator.
11. Pregnancy or inability to exclude pregnancy.
12. Hemodynamic instability per treating physician, including but not limited to: cardiogenic shock, hypotension (systolic blood pressure <90 mmHg), treatment-resistant hypertension (systolic blood pressure >180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medication.
13. Significant allergies or adverse reactions (per Investigator) to iodinated contrast agents, adenosine, regadenoson, or aminophylline. Contraindications include: anaphylactic shock, angioedema.
14. Significant valvular heart disease-at least moderate regurgitation or stenosis.
15. Structural heart disease, including post-corrective procedures.
16. Malignant coronary artery anomaly.
17. History of myocardial infarction.
18. Prior coronary artery bypass grafting (CABG).
19. Prior PCI if the target vessel for evaluation has previously undergone PCI.
20. Chronic total occlusion (CTO) of a coronary artery.
21. Left ventricular ejection fraction (LVEF) ≤35%.
22. Presence of conditions that, in the Investigator's opinion, may significantly change the patient's health status within 122 days.
23. Other relevant comorbidities, infections, addictions, or psychological or social factors that, in the Investigator's opinion, may impair participation in the study or significantly affect patient safety.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Standard of care: FFR, ICA, CCTA; Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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)	18 months

Collaborators and Investigators

• Sponsor: Hemolens Diagnostics Sp. z o.o.
• Collaborators: KCRI

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cardiology; chronic coronary syndrome
• Other Study ID Numbers: Hemolens_Trial_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No