N/A
N=300
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT04582877 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device — 274 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFR measurement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zurich Medical Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device |
274 | — |
| SECONDARY The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease |
89.2; 89.2 | — |
| SECONDARY The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease |
95.2; 95.2 | — |
| SECONDARY Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease |
84.1; 84.1 | — |
| SECONDARY Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease |
96.9; 96.9 | — |
| SECONDARY Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease |
0.9511 | — |
| SECONDARY Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease |
1 | — |
| SECONDARY Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease |
-0.01 | — |
| SECONDARY Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease |
0.9091 | — |
| SECONDARY Device Success Rate Analysis Results for Subjects |
292; 293 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04582877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.