UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010581 |
|---|---|
| Receipt number | 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 08:59:14 |
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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
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
OPINION@tri-kobe.org
Sponsor or person
Institute
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation (TRI)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012349
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