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Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System

NCT04739657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2022-05-11

No results posted yet for this study

Summary

Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Besides, IVUS has already an established role in guidance and optimization of percutaneous coronary intervention. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) results measured by the two different IVUS diagnostic systems.

Conditions

  • Percutaneous Coronary Intervention
  • Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery
  • Left Main Coronary Artery Disease

Interventions

DEVICE

Insight Lifetech IVUS System

The Insight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.

DEVICE

Boston Scientific IVUS System

The Boston Scientific IVUS System is intended for the examination of coronary intravascular pathology only, including Opticross IVUS diagnostic catheter and iLAB IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Zhongda Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Insight Lifetech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junbo Ge, MD, PhD · Zhongshan Hospital of Fudan Unviersity

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-04-27
Completion
2021-04-27

Countries

  • China

Study Locations

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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 NCT04739657 on ClinicalTrials.gov