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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010580
Receipt No. R000012348
Scientific Title OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON
Date of disclosure of the study information 2013/04/24
Last modified on 2019/12/05

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

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate whether the OFDI guided stenting strategy is not inferior to the IVUS guided stenting strategy in terms of the rate of Target Vessel Failure (TVF) at 12 months after PCI procedure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Composite of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization(TVR) at 12 months after PCI(Target Vessel Failure:TVF)
Key secondary outcomes Cardiac death, MI, Clinically-driven Target lesion revascularization(TLR), MACE (composite of cardiac death, MI, TLR), TVR, Stroke, Stent thrombosis, Binary restenosis, Renal dysfunction at 12 months after PCI

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 400 patients
Interventions/Control_2 IVUS Guided PCI in 400 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 eligible for PCI using drug-eluting stent for native coronary artery
2) Patients aged between 20 and 85 years old
3) Patients who has provided written informed consent
Key exclusion criteria 1) Patients with AMI within 3 months
2) Patients with cardiogenic shock
3) Patients with chronic heart failure
4) Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
5) Patients who is currently enrolled other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
6) Patients planned use of bare metal stent
7) 3 vessel diseases
8) Patient who is scheduled to undergo surgical operation within 1 year.
9) Patient on dialysis
10) Target lesion such as:
- Left main coronary artery
- Aorto-Ostial lesion location within 3mm of the aorta junction
- Chronic total occlusion
- Small vessel (<2.5mm)
- Coronary artery bypass graft
- In-stent restenosis
Target sample size 800

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 akasat@wakayama-med.ac.jp

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 takakubo@wakayama-med.ac.jp

Sponsor
Institute Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
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: 10.1093/eurheartj/ehx351
Number of participants that the trial has enrolled 829
Results
Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042). 
Results date posted
2019 Year 12 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient clinical characteristics were well balanced between the groups of OFDI-guided and IVUS-guided PCI. Angiographic lesion characteristics were similar between the two groups except for significantly lower frequency of moderate or severe calcification in theOFDI-guided PCI group.
Participant flow
Between 10 June 2013, and 1 July 2014, we randomly allocated 829 patients to receive OFDI-guided PCI (n = 414) or IVUS-guided PCI
(n= 415). 817 (98.6%) patients comprised the full-analysis set (OFDIguide PCI [n= 412] and IVUS-guide PCI [n= 405]) and 791 (95.4%) patients comprised the per-protocol set (OFDI-guide PCI [n= 401] and IVUS-guide PCI [n=390]).
Adverse events
None
Outcome measures
Within 12months, the target vessel failure (primary endpoint) occurred in 21 (5.2%) of 401 patients in the OFDI-guided PCI groupand in 19 (4.9%) of 390 in the IVUS-guided PCI group.
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=R000012348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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