OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Minimum stent area by OFDI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients participating in the OPINION Trial
- •Patients who has provided written informed consent
排除标准
- •Ineligible patients according to the investigator's judgment
- •Inability or unwillingness to perform required follow up procedures
结局指标
主要结局
Minimum stent area by OFDI
时间窗: at just after the PCI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
Frequency of malapposed struts
时间窗: at just after the PCI
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Minimum stent area by IVUS
时间窗: at just after the PCI
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
Minimum lumen area
时间窗: 8-month follow-up after PCI
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
Dissection
时间窗: at just after the PCI
The investigators will assess "Dissection" by OFDI at post-PCI.
Frequency of uncovered struts
时间窗: 8 months after PCI
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
次要结局
未报告次要终点