Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement
- Conditions
- Myocardial IschemiaCoronary Artery DiseaseCoronary Disease
- Interventions
- Device: TruePhysioTM MicrocatheterDevice: Pressure Wire
- Registration Number
- NCT03541577
- Lead Sponsor
- Insight Lifetech Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- 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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants TruePhysioTM Microcatheter 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 Participants Pressure Wire 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pearson analysis Duration of FFR measurement Pearson analysis of 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.
Slope of Passing-Bablok fit Duration of FFR measurement Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
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.
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.
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.
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.
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.
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).
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.
Trial Locations
- Locations (4)
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