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.
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.
Study Type
OBSERVATIONAL
Enrollment
242
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).
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).
Guangdong General Hospital
Guangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Shanghai Zhongshan Hospital
Shanghai, China
Shenzhen People's Hospital
Shenzhen, China
FFR Measurements
Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.
Time frame: Duration of FFR measurement
Pearson analysis
Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW.
Time frame: Duration of FFR measurement
Slope of Passing-Bablok fit
Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Time frame: Duration of FFR measurement
Intercept of Passing-Bablok fit
Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of FFR Procedure