Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR

The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.

General Inclusion Criteria:

• Patient must be at least 18 years old and less than or equal to 75 years of age
• Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
• Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment

Angiographic Inclusion Criteria:

Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography

General Exclusion Criteria:

• Patients unable to provide informed consent
• Patients in pregnant state
• Known renal insufficiency or failure (serum creatinine level of > 2.5 mg/dL, or on dialysis)
• Allergy to the contrast
• Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
• Spastic bronchial asthma
• ST elevation coronary syndrome
• Hemodynamic instability
• Contraindication to nitroglycerin or ATP
• Current participation in another investigational drug or device clinical study that may affect the FFR measurements

Angiographic Exclusion Criteria:

CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction