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

Coronary Artery Disease Clinical Trial

— SUPREME  

Official title:

Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541577
• Other study ID #: CTP17-001
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2022
• Source: Insight Lifetech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Shanghai Zhongshan Hospital	Shanghai
China	Shenzhen People's Hospital	Shenzhen

Sponsors (5)

Lead Sponsor	Collaborator
Insight Lifetech Co., Ltd.	Guangdong Provincial People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Li C, Yang J, Dong S, Dong L, Chen J, Shen L, Zhang F, Li C, Liu H, Hu X, Hau WK, Qian J, Jeremias A, Wang J, Ge J; SUPREME Study Investigators. Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFR Measurements	Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.	Duration of FFR measurement
Secondary	Pearson analysis	Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW.	Duration of FFR measurement
Secondary	Slope of Passing-Bablok fit	Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.	Duration of FFR measurement
Secondary	Intercept of Passing-Bablok fit	Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.	Duration of FFR measurement
Secondary	Diagnostic FFR concurrence of functionally significant stenosis	Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR =0.80 as the reference.	Duration of FFR measurement
Secondary	Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis	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).	Duration of FFR measurement
Secondary	Device success rate	Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems.	Duration of FFR measurement
Secondary	Mean drift	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.	Duration of FFR measurement
Secondary	Rate of clinically significant drift	Rate of clinically significant drift (drift >0.03), for each system, and comparison between the two systems.	Duration of FFR measurement
Secondary	Rate of device-related adverse effects	Rate of device-related adverse effects, for each system individually, and comparison between the two systems.	Duration of FFR Procedure
Secondary	PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion	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.	Duration of FFR Procedure

External Links

•   ACC 2020 Presentation Number: 1201-031