Coronary Artery Disease Clinical Trial
Official title:
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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