Trial Outcomes & Findings for Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial (NCT NCT04582877)
NCT ID: NCT04582877
Last Updated: 2024-12-02
Results Overview
Diagnostic consistency rate: When the measurement of control device is positive (FFRPW ≤ 0.80) or negative (FFRPW \> 0.80), investigational device is also positive (FFRWS ≤ 0.80) or negative (FFRWS \> 0.80). Each subject will be considered a research unit (for patients with multiple lesions, the method of converting the results of multiple lesions into patient level is defined in the statistical analysis plan), and the coronary artery FFRPW measured by control device will be taken as reference. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
COMPLETED
NA
300 participants
Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.
2024-12-02
Participant Flow
Participant milestones
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
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|---|---|
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Overall Study
STARTED
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300
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Overall Study
COMPLETED
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292
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
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|---|---|
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Overall Study
Did not use device measurement
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5
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Overall Study
No fractional flow reserve test results
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2
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
The Body Mass Index of 9 participants could not be measured.
Baseline characteristics by cohort
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=293 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
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|---|---|
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Age, Continuous
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63.47 Years
STANDARD_DEVIATION 7.6 • n=293 Participants
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Sex: Female, Male
Female
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103 Participants
n=293 Participants
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Sex: Female, Male
Male
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190 Participants
n=293 Participants
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Race/Ethnicity, Customized
Han
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292 Participants
n=293 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=293 Participants
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Region of Enrollment
China
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293 participants
n=293 Participants
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Weight
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68.79 kg
STANDARD_DEVIATION 11.09 • n=293 Participants
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Body Mass Index (BMI)
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25.04 kg/m^2
STANDARD_DEVIATION 3.11 • n=284 Participants • The Body Mass Index of 9 participants could not be measured.
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History of Allergies
No Allergies
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251 Participants
n=293 Participants
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History of Allergies
Yes Allergies
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42 Participants
n=293 Participants
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PRIMARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.Diagnostic consistency rate: When the measurement of control device is positive (FFRPW ≤ 0.80) or negative (FFRPW \> 0.80), investigational device is also positive (FFRWS ≤ 0.80) or negative (FFRWS \> 0.80). Each subject will be considered a research unit (for patients with multiple lesions, the method of converting the results of multiple lesions into patient level is defined in the statistical analysis plan), and the coronary artery FFRPW measured by control device will be taken as reference. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
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|---|---|---|
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Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
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274 Participants
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.After all subjects complete their procedures, using the subjects as the research unit, with the control device's determined coronary artery FFRpw as a reference, and with FFRpw ≤ 0.80 as a positive threshold, the sensitivity of diagnosing coronary heart disease using the trial device is calculated. Sensitivity = Number of subjects with FFRws (≤0.80) / Number of subjects with FFRpw (≤0.80). Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
asymptotic normal method
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89.2 percentage of sensitivity
Interval 80.9 to 97.5
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—
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The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
exact probability method
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89.2 percentage of sensitivity
Interval 79.1 to 95.6
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.After all subjects complete their procedures, using the subjects as the research unit, with the control device's determined coronary artery FFRpw as a reference, and with FFRpw ≤ 0.80 as a positive threshold, the specificity of diagnosing coronary heart disease using the trial device is calculated. Specificity = Number of subjects with FFRws (\>0.80) / Number of subjects with FFRpw (\>0.80). Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
|
The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
asymptotic normal method
|
95.2 Percentage of specificity
Interval 92.1 to 98.2
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—
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The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
exact probability method
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95.2 Percentage of specificity
Interval 91.5 to 97.6
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.using the subjects as the research unit, with the control device's determined coronary artery FFRpw as a reference, and with FFRpw ≤ 0.8 as a positive threshold, the positive predictive value of diagnosing coronary heart disease using the trial device is calculated. PPV = true positive / (true positive + false positive) Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
|
Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease
asymptotic normal method
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84.1 Percentage of PPV
Interval 74.7 to 93.4
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—
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Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease
exact probability method
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84.1 Percentage of PPV
Interval 73.3 to 91.8
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.After all subjects complete their procedures, using the subjects as the research unit, with the control device's determined coronary artery FFRpw as a reference, and with FFRpw ≤ 0.8 as a positive threshold, the negative predictive value of diagnosing coronary heart disease using the trial device is calculated. NPV = true negative / (true negative + false negative) Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
|
Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease
asymptotic normal method
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96.9 Percentage of NPV
Interval 94.3 to 99.4
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—
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Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease
exact probability method
|
96.9 Percentage of NPV
Interval 93.6 to 98.7
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.On a two-dimensional coordinate graph, set the x-axis as the false positive rate (FPR), and the y-axis as the true positive rate (TPR). For the FFRws values measured by the trial device, a point pair of TPR and FPR can be obtained based on its performance on the test sample. Adjust the diagnostic threshold of FFRws to obtain a series of points, connect them in sequence (including the points (0,0) and (1,1)), which forms the ROC curve of FFRws. The value of Area Under Curve (AUC) is the size of the area under the ROC curve. The curve is plotted using MedCalc software. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease
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0.9511 Proportion Probability
Interval 0.92 to 0.98
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.Using the vessel as the research unit, with the trial device's measured coronary artery FFRws value as the y-axis, and the control device's measured coronary FFRpw value as the x-axis, perform linear regression analysis on the FFR measurement results, and record the regression analysis equation, slope, and intercept. The analysis will be conducted at the lesion level. Regression analysis equation: Y=aX + b Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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1 trial device FFRws/control device FFRpw
Interval 0.95 to 1.0
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.Population: Measurements are taken on the same, single Arm/Group with both the trial device as well as the control device. That is, the FFRws and FFRpw are both obtained on the same patient - patients are not separated into groups based on whether the trial device or control device was used. Additionally, the final outcome measure is not intended to report the FFRws and FFRpw values, but to evaluate the agreement between the two measurements using the graph.
Bland-Altman analysis is a statistical method for evaluating the agreement between two measurement methods and for assessing bias. Using the vessel as the research unit, analyze the trial device's measured coronary artery FFRws value and the control device's measured coronary artery FFRpw value using Bland-Altman analysis, and plot the bias graph. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit. In the two-dimensional Cartesian coordinate of the bias graph, the x-axis represents the average value of the FFR measured by the two devices for each diseased vessel, and the y-axis represents the difference between the FFR values determined by the two devices for each diseased vessel. mean: (x-axis): (FFRws+FFRpw) / 2 absolute error (y-axis): FFRws - FFRpw The mean absolute error can then be calculated by taking the average of all absolute errors.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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-0.01 mean absolute error
Standard Deviation 0.03
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—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.After all subjects complete their procedures, using the vessel as the research unit, perform Pearson linear correlation analysis on the trial device's measured coronary artery FFRws value and the control device's measured coronary artery FFRpw value, and record the correlation coefficient. The correlation coefficient is a statistical measure that determines the strength of a linear relationship between two variables, ranging from -1 to 1. A value close to 1 represents a strong positive correlation between the x and y axis values (trail device FFRws and control device FFRpw). Because of the nature of this value, the measure type is "number". The coefficient is determined using the following formula: P = Cov(x,y) / OxOy where: Cov(x,y) = covariance of variables x and y Ox = standard deviation of x Oy = standard deviation of y
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=292 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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0.9091 Correlation Coefficient
|
—
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SECONDARY outcome
Timeframe: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.After all subjects complete their procedures, using the vessel as the research unit, with valid FFRws and FFRpw readings as the standard for successful device use, compare the device success rates of the trial device and the control device. Success rate is determined as the number of units that were performed successfully on the patient. The case was deemed successful if the unit was able to read a valid FFRws and FFRpw reading. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
Outcome measures
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis
n=293 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Predicate Article
n=293 Participants
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
|---|---|---|
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Device Success Rate Analysis Results for Subjects
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292 Number of successful devices
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293 Number of successful devices
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Adverse Events
FFR Measurement in Intermediate-Grade Coronary Stenosis - Subject Device
FFR Measurement in Intermediate-Grade Coronary Stenosis - Control Device
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FFR Measurement in Intermediate-Grade Coronary Stenosis - Subject Device
n=295 participants at risk
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
|
FFR Measurement in Intermediate-Grade Coronary Stenosis - Control Device
n=295 participants at risk
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the predicate article (Abbott PressureWire System).
FFR measurement: FFR is measured sequentially with the test article and the predicate device.
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|---|---|---|
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Surgical and medical procedures
Myocardial injury
|
0.34%
1/295 • Acute - following an initial screening visit, each participant completes their procedure in one visit, with each procedure taking up to 30 minutes. Follow-up time is 48 hours post-operatively. Adverse event data can be collected during the day of the procedure, or up to 48 hours afterwards during the follow up period (Visit 3). During the follow-up period, laboratory tests are performed to check for adverse events, comparing blood and other biochemical changes before and after surgery.
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0.00%
0/295 • Acute - following an initial screening visit, each participant completes their procedure in one visit, with each procedure taking up to 30 minutes. Follow-up time is 48 hours post-operatively. Adverse event data can be collected during the day of the procedure, or up to 48 hours afterwards during the follow up period (Visit 3). During the follow-up period, laboratory tests are performed to check for adverse events, comparing blood and other biochemical changes before and after surgery.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place