- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541577
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement (SUPREME)
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.
TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Guangzhou, China
- Guangdong General Hospital
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Hangzhou, China
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Shanghai, China
- Shanghai Zhongshan Hospital
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Shenzhen, China
- Shenzhen People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
General Inclusion Criteria:
- Age: 18-75 years old
- Subjects with coronary artery disease
- Able to understand and provide signed consent
Angiographic Inclusion Criteria:
- Subject has an intermediate stenosis in a native coronary vessel
- The target stenosis has a reference diameter ≥2.50 mm by visual assessment.
Exclusion Criteria:
General Exclusion Criteria:
- Acute ST-elevation or non-ST-elevation myocardial infarction
- Severe heart failure (NYHA≥IV)
- Left ventricular ejection fraction <30%
- Allergy to adenosine triphosphate (ATP)
- Contraindications for percutaneous coronary intervention (PCI)
Angiographic Exclusion Criteria:
- Target vessel has angiographically visible or suspected thrombus
- Angiographic evidence of a dissection
- Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
Subjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo FFR measurement with the TruePhysioTM Microcatheter and the Pressure Wire
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Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease.
The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
Other Names:
Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease.
The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FFR Measurements
Time Frame: Duration of FFR measurement
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Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.
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Duration of FFR measurement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pearson analysis
Time Frame: Duration of FFR measurement
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Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW.
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Duration of FFR measurement
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Slope of Passing-Bablok fit
Time Frame: Duration of FFR measurement
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Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
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Duration of FFR measurement
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Intercept of Passing-Bablok fit
Time Frame: Duration of FFR measurement
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Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
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Duration of FFR measurement
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Diagnostic FFR concurrence of functionally significant stenosis
Time Frame: Duration of FFR measurement
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Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR ≤0.80 as the reference.
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Duration of FFR measurement
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Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis
Time Frame: Duration of FFR measurement
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Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis at the vessel level with PW FFR as the reference standard (PW FFR ≤0.80 as positive case).
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Duration of FFR measurement
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Device success rate
Time Frame: Duration of FFR measurement
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Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems.
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Duration of FFR measurement
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Mean drift
Time Frame: Duration of FFR measurement
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Mean drift, defined as the absolute difference between Pd/Pa at the equalization position after pullback and 1.00, for each system, and comparison between the two systems.
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Duration of FFR measurement
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Rate of clinically significant drift
Time Frame: Duration of FFR measurement
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Rate of clinically significant drift (drift >0.03), for each system, and comparison between the two systems.
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Duration of FFR measurement
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Rate of device-related adverse effects
Time Frame: Duration of FFR Procedure
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Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
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Duration of FFR Procedure
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PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion
Time Frame: Duration of FFR Procedure
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Comparisons between PW FFR measurements with TruePhysioTM Microcatheter across lesion and with TruePhysioTM Microcatheter not across lesion, including bias, as assessed by Bland-Altman analysis.
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Duration of FFR Procedure
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP17-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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