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Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR)

NCT06726252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-07-15

No results posted yet for this study

Summary

The objective of is study is to validate a novel computational Fractional Flow Reserve (FFR) index method, termed Optical Ultrasonic Flow Ratio (OUFR), based on intravascular imaging including intravascular optical coherence tomography (OCT) and intravascular ultrasound (IVUS), using wire-based FFR as the gold standard. This is a prospective, multi-center, self-controlled clinical trial involving at least four medical centers and recruiting at least 114 subjects based on statistical power analysis.

Participants undoing anticipated percutaneous coronary intervention will be performed:

1. Wire-based FFR measurement
2. Intravascular imaging, including IVUS and integrated OCT-IVUS using a single catheter.

The primary endpoint is to assess patient-level sensitivity, specificity of OUFR computed based on OCT; (2) OUFR based on IVUS, and OUFR based on both OCT and IVUS, using wire-based FFR measurement as the gold standard.

Conditions

Interventions

DEVICE

FFR measurement and intravascular imaging

Participants undoing anticipated percutaneous coronary intervention will be performed wire-based FFR measurement, and intravascular imaging, including IVUS and integrated OCT-IVUS using a single cathete to assess the accurary of OUFR, using wire-based FFR measurement as the gold standard.

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Panovision

    collaborator UNKNOWN

  • Capital Medical University

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Jining Medical University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Bo Yu, MD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-04-07
Completion
2025-06-30

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 NCT06726252 on ClinicalTrials.gov