OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 829
- 试验地点
- 2
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
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.
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 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
排除标准
- •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
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 12 months after PCI
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
次要结局
- Myocardial Infarction (MI)(12 months after PCI)
- MACE (composite of cardiac death, MI, TLR)(12 months after PCI)
- Cardiac death(12 months after PCI)
- Clinically-driven Target lesion revascularization (TLR)(12 months after PCI)
- Stroke(12 months after PCI)
- Stent thrombosis(12 months after PCI)
- Target Vessel Revascularization (TVR)(12 months after PCI)
- Binary restenosis(12 months after PCI)
- Renal dysfunction(8 months after PCI)