Patients 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). Both articles are used within the same participant and the FFR values are statistically compared with each other.
The objective of the 'Pressure guidewire system multi-center, prospective, single-subject design clinical trial' is to evaluate the effectiveness and safety of Zurich Medical's pressure guidewire system (including guidewire with high-fidelity sensors and a unique paired portable display unit), which is used to measure the coronary artery blood fractional flow reserve (FFR) to diagnose coronary artery disease, and to direct a catheter through a blood vessel. This clinical trial uses a multi-center, prospective, single-subject design trial method, using St. Jude Medical's pressure guidewire and Analyzer Express as a control device. The subjects who met the criteria for this study will be registered with the central registration system after enrollment. 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). Both articles are used within the same participant and the FFR values are statistically compared with each other. The subject's FFR of coronary artery stenosis will first be measured using investigational device and recorded, and then measured using control device and recorded. The safety follow-up period is 48 hours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
FFR is measured sequentially with the test article and the predicate device.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
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.
Time frame: 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.
The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
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.
Time frame: 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.
The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
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.
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Time frame: 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.
Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease
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.
Time frame: 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.
Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease
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.
Time frame: 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.
Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease
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.
Time frame: 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.
Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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.
Time frame: 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.
Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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.
Time frame: 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.
Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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
Time frame: 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.
Device Success Rate Analysis Results for Subjects
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.
Time frame: 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.