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

Study Overview
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Brief Summary
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A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements

Detailed Description
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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.

Official Title
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A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Pressure Guidewire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure Guidewire test subject<br>Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. | Device: Pressure Guidewire<br>* Fractional Flow Reserve measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional Flow Reserve (FFR) | All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires Certus®. Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.75-0.80 is generally considered to be associated with myocardial ischemia (MI). Agreement between the method of measurement will be confirmed if both conditions are met: The mean paired difference is within +/- 0.005 | during procedure, 1 hour |