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Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements

NCT05417763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 487

Last updated 2023-12-20

No results posted yet for this study

Summary

TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.

Conditions

Interventions

DEVICE

Randomized physiological measurements by the two systems

To measure physiological indices (FFR, cRR and RFR), either pressure microcatheter or pressure wire enters one patient's body. Whether it is the pressure microcatheter or pressure wire firstly to enter is randomized. After completion of one system's physiological assessment, the other system will follow for its physiological assessment.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Zunyi Medical College

    collaborator OTHER

  • Xiamen Cardiovascular Hospital, Xiamen University

    collaborator OTHER

  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Insight Lifetech Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-07-16
Completion
2022-12-01

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 NCT05417763 on ClinicalTrials.gov