Myocardial IschemiaNCT04582877
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
A study testing FFR measurement in people with Myocardial Ischemia, run by Zurich Medical Inc. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- FFR measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2020to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- FFR measurement
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR measurementDevice
FFR is measured sequentially with the test article and the predicate device.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: FFR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start23 Sep 2020
- Primary completion15 Nov 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582877
- Sponsor's protocol ID
- WXYL-LC-2018001
- Status last verified
- Nov 2024
- First submitted
- 17 Sep 2020
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
- ClinicalTrials.gov ID
- NCT04582877
- Acronym / sponsor ID
- WXYL-LC-2018001
- Conditions
- Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zurich Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFR Measurement in Intermediate-Grade Coronary Stenosis | Other | Device: FFR measurementParticipants 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR measurementFFR is measured sequentially with the test article and the predicate device. | Device | FFR Measurement in Intermediate-Grade Coronary Stenosis |
Primary outcome
Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
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.
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.
9 secondary outcomes
The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
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
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
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
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
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
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
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, MD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR measurement in people with Myocardial Ischemia, run by Zurich Medical Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.