Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-19

Study Completion Date

2019-01-31

Brief Summary

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TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Disease Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

TruePhysioTM Microcatheter

Intervention Type DEVICE

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).

Pressure Wire

Intervention Type DEVICE

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).

Interventions

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TruePhysioTM Microcatheter

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).

Intervention Type DEVICE

Pressure Wire

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).

Intervention Type DEVICE

Other Intervention Names

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FFR Microcatheter PressureWire

Eligibility Criteria

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Inclusion Criteria

* Age: 18-75 years old
* Subjects with coronary artery disease
* Able to understand and provide signed consent

* 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

* 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)

* Target vessel has angiographically visible or suspected thrombus
* Angiographic evidence of a dissection
* Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No