Clinical trial NCT04582877: Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Official title: Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Lead sponsor: Zurich Medical Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
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.
Secondary outcomes:
measure: The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
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.
measure: The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease
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.
measure: Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease
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.
measure: Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease
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.
measure: Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease
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.
measure: Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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.
measure: Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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.
measure: Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease
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.
measure: Device Success Rate Analysis Results for Subjects
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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge, MD
role: PRINCIPAL_INVESTIGATOR
References: