OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON

Study Overview
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Brief Summary
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The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.

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. The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance. We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm. Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: OFDI
* Device: IVUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines Patients aged between 20 and 85 years old Patients who has provided written informed consent Exclusion Criteria: Patients with Acute Myocardial Infarction (AMI) within 3 months Patients with cardiogenic shock Patients with chronic heart failure Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL) Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial. Patients planned use of bare metal stent Patients with 3-vessel diseases Planned surgery within 1 year Patient on dialysis Target lesion such as: Left main coronary artery Aorto-Ostial lesion location within 3mm of the aorta junction Chronic total occlusion Small vessel (reference vessel diameter <2.5mm) Coronary artery bypass graft

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI-guided PCI<br>OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. | Device: OFDI<br>* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI<br>* Other names: Biolimus a9-eluting stent (Nobori stent);|
| Active Comparator: IVUS-guided PCI<br>IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. | Device: IVUS<br>* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI<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 |
| --- | --- | --- |
| Target Vessel Failure (TVF) | The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR) | 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 12 months after PCI | 
| Myocardial Infarction (MI) |  | 12 months after PCI | 
| Clinically-driven Target lesion revascularization (TLR) |  | 12 months after PCI | 
| MACE (composite of cardiac death, MI, TLR) |  | 12 months after PCI | 
| Target Vessel Revascularization (TVR) |  | 12 months after PCI | 
| Stroke |  | 12 months after PCI | 
| Stent thrombosis |  | 12 months after PCI | 
| Binary restenosis |  | 12 months after PCI | 
| Renal dysfunction |  | 8 months 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