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

NCT03541577 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2022-05-27

No results posted yet for this study

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.

Conditions

Interventions

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).

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).

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Insight Lifetech Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541577 on ClinicalTrials.gov