Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR Measurement in Intermediate-Grade Coronary Stenosis | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR measurement | Device | FFR is measured sequentially with the test article and the predicate device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study started with 300 participants, however, 7 patients never completed the study. Additionally, 1 participant violated protocol, however, their baseline characteristics were still recorded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | 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. |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FFR Measurement in Intermediate-Grade Coronary Stenosis - Subject Device | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial injury | Surgical and medical procedures | Systematic Assessment | perioperative |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Chan | Zurich Medical | (612) 889-9412 | cchan@zurichmed.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Jul 31, 2024 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | The Body Mass Index of 9 participants could not be measured. | Mean | Standard Deviation | kg/m^2 |
|
| History of Allergies | Count of Participants | 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. |
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of sensitivity | 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. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentage of specificity | 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. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentage of PPV | 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. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentage of NPV | 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. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Proportion Probability | 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. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | trial device FFRws/control device FFRpw | 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. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mean absolute error | 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. |
|
|
|
| Secondary | 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 | Posted | Number | Correlation Coefficient | 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. |
|
|
|
| Secondary | 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. | Posted | Number | Number of successful devices | 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. |
|
|
|
| 0 |
| 295 |
| 0 |
| 295 |
| 1 |
| 295 |
| EG001 | FFR Measurement in Intermediate-Grade Coronary Stenosis - Control Device | 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. | 0 | 295 | 0 | 295 | 0 | 295 |
Not provided
Not provided