OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

July 13, 2016 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.

This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI.

We will then assess lesions by OFDI at a 8-month follo-up.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

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

  • Japan
    • Wakayama Prefecture
      • Wakayama, Wakayama Prefecture, Japan, 641-8510
        • Wakayama Medical University

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients participating in the OPINION Trial
  • Patients who has provided written informed consent

Exclusion Criteria:

  • Ineligible patients according to the investigator's judgment
  • Inability or unwillingness to perform required follow up procedures

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OFDI-guided PCI & IVUS
  • Assessment by IVUS at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Device: OFDI-guided PCI & IVUS
  • Assessment by IVUS at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Other Names:
  • LUNAWAVE
  • Biolimus A9-eluting stent (Nobori stent)
  • OFDI
Active Comparator: IVUS-guided PCI & OFDI
  • Assessment by OFDI at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Device: IVUS-guided PCI & OFDI
  • Assessment by OFDI at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Other Names:
  • VISIWAVE
  • ViewIT
  • Biolimus A9-eluting stent (Nobori stent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum stent area by OFDI
Time Frame: at just after the PCI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
at just after the PCI
Frequency of malapposed struts
Time Frame: at just after the PCI
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
at just after the PCI
Dissection
Time Frame: at just after the PCI
The investigators will assess "Dissection" by OFDI at post-PCI.
at just after the PCI
Minimum stent area by IVUS
Time Frame: at just after the PCI
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
at just after the PCI
Frequency of uncovered struts
Time Frame: 8 months after PCI
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
8 months after PCI
Minimum lumen area
Time Frame: 8-month follow-up after PCI
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
8-month follow-up after PCI

Collaborators and Investigators

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

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Wakayama Medical University

Investigators

  • Principal Investigator: Takashi Akasaka, MD, PhD, Wakayama Medical University

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.

General Publications

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

June 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRICVD1311
  • UMIN000010581 (Registry Identifier: UMIN Clinical Trial Registry)

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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