Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Minimum lumen area assessed by OFDI
研究概览
简要总结
The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.
详细描述
Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences suggest potential advantage of intracoronary imaging guidance in reducing the risk of major adverse cardiac events after stent implantation over conventional PCI under angiographic guidance alone. IVUS has been clinically used in two decades and it is known as one of the most dominant intracoronary imaging technique. OFDI is a new light-based intracoronary imaging technology which provides higher image resolution and higher-speed pullback compared to those of IVUS. Given the different properties between ultrasound-based IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques would be different.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.
排除标准
- •Renal insufficiency with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2
- •Left ventricular ejection fraction (LVEF) <30% or history of congestive heart failure
- •Acute coronary syndrome within 7 days after onset
- •Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet therapy for one year after the index procedure
- •Life expectancy within one year
- •Lesion length estimated by quantitative coronary angiography (QCA) >28mm
- •Chronic total occlusion
- •Left main stem lesion
- •Bifurcation requiring side branch balloon dilatation
- •Severely calcified lesion
- •Other conditions by which physicians in charge judged inappropriate to enroll the patients because of safety concern.
研究组 & 干预措施
IVUS-guided PCI
干预措施: IVUS (Device)
OFDI-guided PCI
干预措施: OFDI (Device)
结局指标
主要结局
Minimum lumen area assessed by OFDI
时间窗: 8 months
次要结局
- Quantitative Coronary Angiography (QCA)(8 months)
- Target vessel myocardial infarction(8 months)
- Target lesion revascularization(8 months)
- Tissue coverage of stent struts assessed by OFDI(8 months)
- Cardiovascular mortality(8 months)
- Apposition of stent struts assessed by OFDI(8 months)
研究者
Yukio Ozaki
Professor, Department of Cardiology
Fujita Health University