This study will evaluate the safety and efficacy of the fractional flow reserve (FFR) and constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, with respect to the FFR and resting full-cycle ratio (RFR) by the Pressure Wire.~The diagnostic accuracy of FFR by the TruePhysio pressure microcatheter system is evaluated, using the FFR by the Pressure Wire system as reference.~The diagnostic accuracy of the hybrid cRR-FFR scheme by the TruePhysio pressure microcatheter is evaluated, using its own FFR as reference;~The diagnostic accuracy of the hybrid RFR-FFR scheme by the Pressure Wire system is evaluated, using its own FFR as reference.~The hybrid scheme for cRR-FFR (pressure microcatheter system), or RFR-FFR (pressure wire system), is defined as following:~if cRR or RFR of the target vessel is <0.86, it is diagnosed as functionally positive in myocardial ischemia;~if cRR or RFR of the target vessel is >0.93, it is diagnosed as functionally negative in myocardial ischemia;~if cRR or RFR of the target vessel is between 0.86 and 0.93 (including 0.86 and 0.93), the diagnostic criterion is superseded by that of FFR, which is:~if FFR of the target vessel is > 0.80, it is diagnosed as functionally negative in myocardial ischemia;~if FFR of the target vessel is ≤ 0.80, it is diagnosed as functionally positive in myocardial ischemia.~A total of 487 patients are anticipated to be recruited from 11 centers in China.
TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and has been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, with respect to the physiological indices measured by the Pressure Wire.