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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OFDI
IVUS
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wakayama Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OFDI-guided PCI

IVUS-guided PCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Target Vessel Failure (TVF)
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)

Secondary Outcome Measures

Cardiac death
Myocardial Infarction (MI)
Clinically-driven Target lesion revascularization (TLR)
MACE (composite of cardiac death, MI, TLR)
Target Vessel Revascularization (TVR)
Stroke
Stent thrombosis
Binary restenosis
Renal dysfunction

Full Information

First Posted
May 26, 2013
Last Updated
July 13, 2016
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01873027
Brief Title
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
Acronym
OPINION
Official Title
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
829 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFDI-guided PCI
Arm Type
Experimental
Arm Description
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.
Arm Title
IVUS-guided PCI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OFDI
Other Intervention Name(s)
LUNAWAVE, Fastview, Biolimus a9-eluting stent (Nobori stent)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
IVUS
Other Intervention Name(s)
VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)
Intervention Description
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
Primary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Description
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
Time Frame
12 months after PCI
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
12 months after PCI
Title
Myocardial Infarction (MI)
Time Frame
12 months after PCI
Title
Clinically-driven Target lesion revascularization (TLR)
Time Frame
12 months after PCI
Title
MACE (composite of cardiac death, MI, TLR)
Time Frame
12 months after PCI
Title
Target Vessel Revascularization (TVR)
Time Frame
12 months after PCI
Title
Stroke
Time Frame
12 months after PCI
Title
Stent thrombosis
Time Frame
12 months after PCI
Title
Binary restenosis
Time Frame
12 months after PCI
Title
Renal dysfunction
Time Frame
8 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Akasaka, MD, PhD
Organizational Affiliation
Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wakayama Medical University
City
Wakayama
State/Province
Wakayama Prefecture
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29121226
Citation
Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.
Results Reference
derived

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

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