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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OFDI-guided PCI & IVUS
IVUS-guided PCI & OFDI
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 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

Sites / Locations

  • Wakayama Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OFDI-guided PCI & IVUS

IVUS-guided PCI & OFDI

Arm Description

Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up

Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up

Outcomes

Primary Outcome Measures

Minimum stent area by OFDI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
Frequency of malapposed struts
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Dissection
The investigators will assess "Dissection" by OFDI at post-PCI.
Minimum stent area by IVUS
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
Frequency of uncovered struts
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
Minimum lumen area
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.

Secondary Outcome Measures

Full Information

First Posted
May 27, 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
NCT01873222
Brief Title
OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Official Title
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
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
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.
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.

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFDI-guided PCI & IVUS
Arm Type
Experimental
Arm Description
Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up
Arm Title
IVUS-guided PCI & OFDI
Arm Type
Active Comparator
Arm Description
Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up
Intervention Type
Device
Intervention Name(s)
OFDI-guided PCI & IVUS
Other Intervention Name(s)
OFDI, LUNAWAVE, Biolimus A9-eluting stent (Nobori stent)
Intervention Description
Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up
Intervention Type
Device
Intervention Name(s)
IVUS-guided PCI & OFDI
Other Intervention Name(s)
VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)
Intervention Description
Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up
Primary Outcome Measure Information:
Title
Minimum stent area by OFDI
Description
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
Time Frame
at just after the PCI
Title
Frequency of malapposed struts
Description
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Time Frame
at just after the PCI
Title
Dissection
Description
The investigators will assess "Dissection" by OFDI at post-PCI.
Time Frame
at just after the PCI
Title
Minimum stent area by IVUS
Description
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
Time Frame
at just after the PCI
Title
Frequency of uncovered struts
Description
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
Time Frame
8 months after PCI
Title
Minimum lumen area
Description
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
Time Frame
8-month follow-up 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 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
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
28917678
Citation
Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T; OPINION Investigators. Optical Frequency Domain Imaging Versus Intravascular Ultrasound in Percutaneous Coronary Intervention (OPINION Trial): Results From the OPINION Imaging Study. JACC Cardiovasc Imaging. 2018 Jan;11(1):111-123. doi: 10.1016/j.jcmg.2017.06.021. Epub 2017 Oct 5.
Results Reference
derived

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

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