UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010580 |
|---|---|
| Receipt number | 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 08:38:29 |
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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
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
takakubo@wakayama-med.ac.jp
Sponsor or person
Institute
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
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: 10.1093/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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012348
