OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
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|ClinicalTrials.gov Identifier: NCT01873027|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: OFDI Device: IVUS||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||829 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: OFDI-guided PCI
Active Comparator: IVUS-guided PCI
- Target Vessel Failure (TVF) [ Time Frame: 12 months after PCI ]The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
- Cardiac death [ Time Frame: 12 months after PCI ]
- Myocardial Infarction (MI) [ Time Frame: 12 months after PCI ]
- Clinically-driven Target lesion revascularization (TLR) [ Time Frame: 12 months after PCI ]
- MACE (composite of cardiac death, MI, TLR) [ Time Frame: 12 months after PCI ]
- Target Vessel Revascularization (TVR) [ Time Frame: 12 months after PCI ]
- Stroke [ Time Frame: 12 months after PCI ]
- Stent thrombosis [ Time Frame: 12 months after PCI ]
- Binary restenosis [ Time Frame: 12 months after PCI ]
- Renal dysfunction [ Time Frame: 8 months after PCI ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873027
|Wakayama Medical University|
|Wakayama, Wakayama Prefecture, Japan, 641-8510|
|Principal Investigator:||Takashi Akasaka, MD, PhD||Wakayama Medical University|