UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000010581
Receipt No. R000012349
Scientific Title OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) - Imaging Study
Date of disclosure of the study information 2013/04/24
Last modified on 2019/12/05 (Ver. 7)

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Basic information
Public title OPtical frequency domain imaging vs. INtravascular ultrasound
in percutaneous coronary InterventiON (OPINION) - Imaging Study
Acronym OPINION Trial - Imaging Study
Scientific Title OPtical frequency domain imaging vs. INtravascular ultrasound
in percutaneous coronary InterventiON (OPINION) - Imaging Study
Scientific Title:Acronym OPINION Trial - Imaging Study
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is the subs-study of OPINION Trial (UMIN000010580).
The purpose of this study is to evaluate how the OFDI or IVUS imaging technology influence to the PCI strategy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes - Minimum stent area by OFDI post PCI
- % of Mal struts by OFDI post PCI
- Dissection by OFDI post PCI
- Minimum stent area by IVUS post PCI
- %uncovered struts by OFDI at 8 month after PCI
- Minimum lumen area by OFDI at 8 month after PCI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 OFDI Guided PCI in 50 patients
Interventions/Control_2 IVUS Guided PCI in 50 patients
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients participating in the OPINION Trial
2) Patients who has provided written informed consent
Key exclusion criteria 1) Considered as unsuitable by the investigator
2) Patients deemed as difficult to perform additional OFDI or IVUS procedure
3) Patients deemed as difficult to perform OFDI procedure at 8 month after PCI
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Akasaka
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama 641-8510, Japan
TEL 073-441-0621
Email OPINION@tri-kobe.org

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kubo
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama 641-8510, Japan
TEL 073-441-0621
Homepage URL
Email OPINION@tri-kobe.org

Sponsor
Institute Translational Research Informatics Center, Foundation for Biomedical Research and Innovation (TRI)
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Medical University
Address 811-1Kimiidera, Wakayama
Tel 073-441-0621
Email OPINION@tri-kobe.org

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 24 Day

Related information
URL releasing protocol doi: 10.1016/j.jjcc.2015.11.007
Publication of results Published

Result
URL related to results and publications doi: 10.1016/j.jcmg.2017.06.021
Number of participants that the trial has enrolled 106
Results 
The minimal lumen area was comparable in both groups (p = 0.18).
Results date posted
2019 Year 12 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Coronary artery disease
Participant flow 
Of 829 patients enrolled in the OPINION trial, 106 were included in the present imaging substudy.103 patients underwent either OFDI-guided (n = 54) or IVUS-guided (n = 49) PCI.
Adverse events 
No
Outcome measures 
The minimal lumen area was comparable in both groups (p = 0.18).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 19 Day
Date of IRB
2013 Year 04 Month 19 Day
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 24 Day
Last modified on
2019 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012349