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

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)

The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.

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.

The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.

We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.

Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.

Study Type

Interventional

Enrollment (Actual)

829

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 with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
  • Patients aged between 20 and 85 years old
  • Patients who has provided written informed consent

Exclusion Criteria:

  • Patients with Acute Myocardial Infarction (AMI) within 3 months
  • Patients with cardiogenic shock
  • Patients with chronic heart failure
  • Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
  • Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
  • Patients planned use of bare metal stent
  • Patients with 3-vessel diseases
  • Planned surgery within 1 year
  • Patient on dialysis

  • Target lesion such as:

    • Left main coronary artery
    • Aorto-Ostial lesion location within 3mm of the aorta junction
    • Chronic total occlusion
    • Small vessel (reference vessel diameter <2.5mm)
    • Coronary artery bypass graft

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OFDI-guided PCI
  • OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.
Device: OFDI
  • OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
Other Names:
  • LUNAWAVE
  • Fastview
  • Biolimus a9-eluting stent (Nobori stent)
Active Comparator: IVUS-guided PCI
  • IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.
Device: IVUS
  • IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
Other Names:
  • VISIWAVE
  • ViewIT
  • Biolimus A9-eluting stent (Nobori stent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure (TVF)
Time Frame: 12 months after PCI
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
12 months after PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: 12 months after PCI
12 months after PCI
Myocardial Infarction (MI)
Time Frame: 12 months after PCI
12 months after PCI
Clinically-driven Target lesion revascularization (TLR)
Time Frame: 12 months after PCI
12 months after PCI
MACE (composite of cardiac death, MI, TLR)
Time Frame: 12 months after PCI
12 months after PCI
Target Vessel Revascularization (TVR)
Time Frame: 12 months after PCI
12 months after PCI
Stroke
Time Frame: 12 months after PCI
12 months after PCI
Stent thrombosis
Time Frame: 12 months after PCI
12 months after PCI
Binary restenosis
Time Frame: 12 months after PCI
12 months after PCI
Renal dysfunction
Time Frame: 8 months after PCI
8 months 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 26, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 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

  • TRICVD1225
  • UMIN000010580 (Registry Identifier: UMIN Clinical Trials 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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