Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial

Study Overview
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Brief Summary
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Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other.

Official Title
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Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Device: FFR measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years old, gender-unrestricted, non-pregnant female; Understand and be willing to sign an informed consent form; Diagnosed with coronary heart disease; Intrusive ICA and FFR measurement are needed; Visual coronary angiography showed at least one moderate stenosis lesion (diameter stenosis of 30% - 70%) on the coronary artery with diameter ≥ 2.5mm Exclusion Criteria: Patient who do not understand or are unwilling to sign an informed consent form; Has a history of myocardial infarction; Patient with other serious diseases are not suitable for clinical trials, such as a complex congenital heart disease history, severe heart failure(NYHA cardiac function level IV), long QT syndrome, severe hypertension, Severe asthma, severe chronic obstructive pulmonary disease, liver and kidney dysfunction and other serious infections and critical illnesses; Coronary intervention surgery contraindications; Patient with ATP contraindications (ATP contraindications: sinus syndrome, sinus insufficiency and the elderly with cautious use or no use); The clinical manifestations of patients show acute instability, including acute chest pain (sudden appearance), cardiogenic shock, unstable blood pressure (systolic pressure less than 90mmHg), severe congestive heart failure or acute pulmonary edema; The angiography shown or suspect of thrombosis; The angiography shown or suspect of dissection; Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion; There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.

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 |
| --- | --- |
| Other: FFR Measurement in Intermediate-Grade Coronary Stenosis<br>Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). | Device: FFR measurement<br>* FFR is measured sequentially with the test article and the predicate device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared FFR Measurement Between Test Article and Predicate Article |  | Acute |