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

NCT07472634 | Completed FDA Device

• 1 other identifier: Hemolens_Trial_2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

chronic coronary syndrome; cardiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Sensitivity, specificity, PPV, NPV, and accuracy of the Cardiolens® Platform for detecting functionally significant stenoses

  Up to 18 months

• AUC ROC comparison between Cardiolens® Platform and standard imaging modalities for identifying arteries requiring revascularization

  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

  18 months

• Diagnostic accuracy of the Cardiolens® Platform on a per-patient level

  18 months

• Diagnostic accuracy of the Cardiolens® Platform for predicting performed coronary revascularization (per-patient)

  18 months

Study Arms (1)

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); Procedure: ICA (Invasive Coronary Angiography); Procedure: FFR (Fractional Flow Reserve); Device: CNBP measurement; Device: Cardiolens Platform

Interventions

CCTA (Coronary Computed Tomography Angiography) PROCEDURE

Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.

Standard of care: FFR, ICA, CCTA

ICA (Invasive Coronary Angiography) PROCEDURE

Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.

Standard of care: FFR, ICA, CCTA

FFR (Fractional Flow Reserve) PROCEDURE

Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.

Standard of care: FFR, ICA, CCTA

CNBP measurement DEVICE

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.

Standard of care: FFR, ICA, CCTA

Cardiolens Platform DEVICE

Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.

Standard of care: FFR, ICA, CCTA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Positive medical history suggestive of chronic coronary syndrome (CCS)

You may qualify if:

• Age 18-90 years.
• Signed informed consent to participate in the study.
• Positive medical history suggestive of chronic coronary syndrome (CCS).
• 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.
• Planned ICA with the intention to perform FFR measurement no later than 122 days after the CCTA.

You may not qualify if:

• Presence of myocardial bridging on CCTA causing \>50% systolic narrowing of an epicardial coronary artery, per Investigator's assessment.
• Complications occurring during CCTA that reduce the safety or feasibility of CTP (per treating physician decision).
• Stenosis of the left main coronary artery \>40%.
• Myocardial infarction occurring between CCTA and ICA, documented by elevated cardiac biomarkers (troponin, myoglobin) or new wall motion abnormalities or new coronary occlusion.
• 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.
• Atrioventricular block (type II-III), prolonged QT interval, or sick sinus syndrome.
• Renal insufficiency (creatinine ≥1.6 and/or glomerular filtration rate \<30 ml/m²) or renal failure requiring dialysis.
• Persistent atrial fibrillation.
• BMI \>40.
• Implanted pacemaker or internal cardioverter-defibrillator.
• Pregnancy or inability to exclude pregnancy.
• 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.
• Significant allergies or adverse reactions (per Investigator) to iodinated contrast agents, adenosine, regadenoson, or aminophylline. Contraindications include: anaphylactic shock, angioedema.
• Significant valvular heart disease-at least moderate regurgitation or stenosis.
• Structural heart disease, including post-corrective procedures.

Sponsors & Collaborators

• Hemolens Diagnostics Sp. z o.o.: lead
• KCRI: collaborator

Study Sites (8)

The University Clinical Centre

Gdansk, Poland

Location

The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University

Katowice, Poland

Location

Świętokrzyskie Cardiology Center, Regional Combined Hospital in Kielce

Kielce, Poland

Location

The John Paul II Specialist Hospital in Kraków

Krakow, Poland

Location

University Hospital in Kraków

Krakow, Poland

Location

The Cardinal Stefan Wyszyński National Institute of Cardiology

Warsaw, Poland

Location

The 4th Military Teaching Hospital

Wroclaw, Poland

Location

The Jan Mikulicz-Radecki University Teaching Hospital

Wroclaw, Poland

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 16, 2026
• Study Start: October 18, 2023
• Primary Completion: June 26, 2025
• Study Completion: July 4, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

PL (8)