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

Inclusion criteria

• 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.
• Stable treatment for CCS without the need for dose adjustments for at least 30 days prior to study inclusion.

Exclusion criteria

• 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.
• Malignant coronary artery anomaly.
• History of myocardial infarction.
• Prior coronary artery bypass grafting (CABG).
• Prior PCI if the target vessel for evaluation has previously undergone PCI.
• Chronic total occlusion (CTO) of a coronary artery.
• Left ventricular ejection fraction (LVEF) ≤35%.
• Presence of conditions that, in the Investigator's opinion, may significantly change the patient's health status within 122 days.
• 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.