Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement (SUPREME)

Insight Lifetech

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Treatments: Device: Pressure Wire; Device: TruePhysioTM Microcatheter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03541577

CTP17-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

242 participants in 1 patient group

Participants

Description:

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

Treatment:

Device: TruePhysioTM Microcatheter

Device: Pressure Wire