OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
NCT ID: NCT01873222
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2013-06-30
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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OFDI-guided PCI & IVUS
* Assessment by IVUS at post-PCI
* Assessment by OFDI at a 8-month follow-up
OFDI-guided PCI & IVUS
* Assessment by IVUS at post-PCI
* Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDI
* Assessment by OFDI at post-PCI
* Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDI
* Assessment by OFDI at post-PCI
* Assessment by OFDI at a 8-month follow-up
Interventions
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OFDI-guided PCI & IVUS
* Assessment by IVUS at post-PCI
* Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDI
* Assessment by OFDI at post-PCI
* Assessment by OFDI at a 8-month follow-up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who has provided written informed consent
Exclusion Criteria
* Inability or unwillingness to perform required follow up procedures
20 Years
85 Years
ALL
No
Sponsors
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Wakayama Medical University
OTHER
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
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Principal Investigators
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Takashi Akasaka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wakayama Medical University
Locations
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Wakayama Medical University
Wakayama, Wakayama, Japan
Countries
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References
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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.
Other Identifiers
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UMIN000010581
Identifier Type: REGISTRY
Identifier Source: secondary_id
TRICVD1311
Identifier Type: -
Identifier Source: org_study_id
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