NCT05417763

Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements

Pressure Microcatheter for Physiological Measurements - A Prospective, Multicenter, Randomized Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 487 (actual)
• Sponsor: Insight Lifetech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have 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, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.

Detailed description

This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire. The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference; Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the 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: * the gray zone is defined as where the sensitivity and specificity are equal, shown as \[A, B\]. * if cRR or RFR of the target vessel is \<A, it is diagnosed as functionally positive in myocardial ischemia; * if cRR or RFR of the target vessel is \>B, it is diagnosed as functionally negative in myocardial ischemia; * if cRR or RFR of the target vessel is between A and B (including A and B), 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.

Conditions

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	Randomized physiological measurements by the two systems	To measure physiological indices (FFR, cRR and RFR), either pressure microcatheter or pressure wire enters one patient's body. Whether it is the pressure microcatheter or pressure wire firstly to enter is randomized. After completion of one system's physiological assessment, the other system will follow for its physiological assessment.

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-07-16
• Completion: 2022-12-01
• First posted: 2022-06-14
• Last updated: 2023-12-20

Locations

11 sites across 1 country: China