Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement

Study Overview
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Brief Summary
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TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.

Detailed Description
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Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire. TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.

Official Title
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Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study

Conditions
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia

Intervention / Treatment
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* Device: TruePhysioTM Microcatheter
* Device: Pressure Wire


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Age: 18-75 years old Subjects with coronary artery disease Able to understand and provide signed consent Angiographic Inclusion Criteria: Subject has an intermediate stenosis in a native coronary vessel The target stenosis has a reference diameter ≥2.50 mm by visual assessment. Exclusion Criteria: General Exclusion Criteria: Acute ST-elevation or non-ST-elevation myocardial infarction Severe heart failure (NYHA≥IV) Left ventricular ejection fraction <30% Allergy to adenosine triphosphate (ATP) Contraindications for percutaneous coronary intervention (PCI) Angiographic Exclusion Criteria: Target vessel has angiographically visible or suspected thrombus Angiographic evidence of a dissection Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Subjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo FFR measurement with the TruePhysioTM Microcatheter and the Pressure Wire | Device: TruePhysioTM Microcatheter<br>* Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).<br>* Other names: FFR Microcatheter;Device: Pressure Wire<br>* Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).<br>* Other names: PressureWire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFR Measurements | Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis. | Duration of FFR measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson analysis | Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW. | Duration of FFR measurement | 
| Slope of Passing-Bablok fit | Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW. | Duration of FFR measurement | 
| Intercept of Passing-Bablok fit | Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW. | Duration of FFR measurement | 
| Diagnostic FFR concurrence of functionally significant stenosis | Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR ≤0.80 as the reference. | Duration of FFR measurement | 
| Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis | Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis at the vessel level with PW FFR as the reference standard (PW FFR ≤0.80 as positive case). | Duration of FFR measurement | 
| Device success rate | Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems. | Duration of FFR measurement | 
| Mean drift | Mean drift, defined as the absolute difference between Pd/Pa at the equalization position after pullback and 1.00, for each system, and comparison between the two systems. | Duration of FFR measurement | 
| Rate of clinically significant drift | Rate of clinically significant drift (drift >0.03), for each system, and comparison between the two systems. | Duration of FFR measurement | 
| Rate of device-related adverse effects | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. | Duration of FFR Procedure | 
| PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion | Comparisons between PW FFR measurements with TruePhysioTM Microcatheter across lesion and with TruePhysioTM Microcatheter not across lesion, including bias, as assessed by Bland-Altman analysis. | Duration of FFR Procedure |