OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

Study Overview
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Brief Summary
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This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

Detailed Description
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Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment. 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.

Official Title
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OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: OFDI-guided PCI & IVUS
* Device: IVUS-guided PCI & OFDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients participating in the OPINION Trial Patients who has provided written informed consent Exclusion Criteria: Ineligible patients according to the investigator's judgment Inability or unwillingness to perform required follow up procedures

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI-guided PCI & IVUS<br>Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up | Device: OFDI-guided PCI & IVUS<br>* Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up<br>* Other names: Biolimus A9-eluting stent (Nobori stent);|
| Active Comparator: IVUS-guided PCI & OFDI<br>Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up | Device: IVUS-guided PCI & OFDI<br>* Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up<br>* Other names: Biolimus A9-eluting stent (Nobori stent);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum stent area by OFDI | The investigators will assess Minimum stent area by OFDI at post-PCI. | at just after the PCI | 
| Frequency of malapposed struts | The investigators will assess Frequency of malapposed struts by OFDI at post-PCI. | at just after the PCI | 
| Dissection | The investigators will assess Dissection by OFDI at post-PCI. | at just after the PCI | 
| Minimum stent area by IVUS | The investigators will assess Minimum stent area by IVUS at post-PCI. | at just after the PCI | 
| Frequency of uncovered struts | The investigators will assess Frequency of uncovered struts by OFDI at 8 months after PCI. | 8 months after PCI | 
| Minimum lumen area | The investigators will assess Minimum lumen area by OFDI at 8 months after PCI. | 8-month follow-up after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound