Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
Conditions
Brief summary
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
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.
Interventions
DEVICETruePhysioTM Microcatheter
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).
DEVICEPressure Wire
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).
Sponsors
Shanghai Zhongshan Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Guangdong Provincial People's Hospital
Shenzhen People's Hospital
Insight Lifetech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFR Measurements | Duration of FFR measurement | Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slope of Passing-Bablok fit | Duration of FFR measurement | Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW. |
| Intercept of Passing-Bablok fit | Duration of FFR measurement | Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW. |
| Diagnostic FFR concurrence of functionally significant stenosis | Duration of FFR measurement | Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR ≤0.80 as the reference. |
| Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis | Duration of FFR measurement | 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). |
| Pearson analysis | Duration of FFR measurement | Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW. |
| Mean drift | Duration of FFR measurement | 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. |
| Rate of clinically significant drift | Duration of FFR measurement | Rate of clinically significant drift (drift \>0.03), for each system, and comparison between the two systems. |
| Rate of device-related adverse effects | Duration of FFR Procedure | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. |
| PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion | Duration of FFR Procedure | 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. |
| Device success rate | Duration of FFR measurement | Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems. |
Countries
China
Outcome results
None listed