Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04582877

Enrollment

300

Registered

2020-10-12

Start date

2020-09-23

Completion date

2024-04-30

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Brief summary

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.

Detailed description

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.

Interventions

DEVICEFFR measurement

FFR is measured sequentially with the test article and the predicate device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age 18 to 75 years old, gender-unrestricted, non-pregnant female; * Understand and be willing to sign an informed consent form; * Diagnosed with coronary heart disease; * Intrusive ICA and FFR measurement are needed; * Visual coronary angiography showed at least one moderate stenosis lesion (diameter stenosis of 30% - 70%) on the coronary artery with diameter ≥ 2.5mm

Exclusion criteria

* Patient who do not understand or are unwilling to sign an informed consent form; * Has a history of myocardial infarction; * Patient with other serious diseases are not suitable for clinical trials, such as a complex congenital heart disease history, severe heart failure(NYHA cardiac function level IV), long QT syndrome, severe hypertension, Severe asthma, severe chronic obstructive pulmonary disease, liver and kidney dysfunction and other serious infections and critical illnesses; * Coronary intervention surgery contraindications; * Patient with ATP contraindications (ATP contraindications: sinus syndrome, sinus insufficiency and the elderly with cautious use or no use); * The clinical manifestations of patients show acute instability, including acute chest pain (sudden appearance), cardiogenic shock, unstable blood pressure (systolic pressure less than 90mmHg), severe congestive heart failure or acute pulmonary edema; * The angiography shown or suspect of thrombosis; * The angiography shown or suspect of dissection; * Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion; * There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device	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.

Secondary

Measure	Time frame	Description
The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease	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.
Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease	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.
Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease	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.
Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease	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.
The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease	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.
Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease	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 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.
Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease	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
Device Success Rate Analysis Results for Subjects	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.
Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease	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.

Countries

China

Participant flow

Participants by arm

Arm	Count
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.	293
Total	293

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did not use device measurement	5
Overall Study	No fractional flow reserve test results	2
Overall Study	Protocol Violation	1

Baseline characteristics

Characteristic	FFR Measurement in Intermediate-Grade Coronary Stenosis
Age, Continuous	63.47 Years STANDARD_DEVIATION 7.6
Body Mass Index (BMI)	25.04 kg/m^2 STANDARD_DEVIATION 3.11
History of Allergies No Allergies	251 Participants
History of Allergies Yes Allergies	42 Participants
Race/Ethnicity, Customized Han	292 Participants
Race/Ethnicity, Customized Other	1 Participants
Region of Enrollment China	293 participants
Sex: Female, Male Female	103 Participants
Sex: Female, Male Male	190 Participants
Weight	68.79 kg STANDARD_DEVIATION 11.09

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 295	0 / 295
other Total, other adverse events	1 / 295	0 / 295
serious Total, serious adverse events	0 / 295	0 / 295

Outcome results

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.