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

May 23, 2022 updated by: Insight Lifetech Co., Ltd.

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

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.

Study Overview

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

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease for whom FFR measurement is thought to be clinically indicated.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • FFR 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).
Other Names:
  • PressureWire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FFR Measurements
Time Frame: Duration of FFR measurement
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pearson analysis
Time Frame: Duration of FFR measurement
Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW.
Duration of FFR measurement
Slope of Passing-Bablok fit
Time Frame: Duration of FFR measurement
Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Duration of FFR measurement
Intercept of Passing-Bablok fit
Time Frame: Duration of FFR measurement
Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Duration of FFR measurement
Diagnostic FFR concurrence of functionally significant stenosis
Time Frame: Duration of FFR measurement
Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR ≤0.80 as the reference.
Duration of FFR measurement
Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis
Time Frame: Duration of FFR measurement
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
Device success rate
Time Frame: Duration of FFR measurement
Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems.
Duration of FFR measurement
Mean drift
Time Frame: Duration of FFR measurement
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
Rate of clinically significant drift
Time Frame: Duration of FFR measurement
Rate of clinically significant drift (drift >0.03), for each system, and comparison between the two systems.
Duration of FFR measurement
Rate of device-related adverse effects
Time Frame: Duration of FFR Procedure
Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
Duration of FFR Procedure
PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion
Time Frame: Duration of FFR Procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2018

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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