Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Rate of target vessel failure (TVF)
研究概览
简要总结
The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
详细描述
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
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
盲法说明
No blinding process, open label design
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 19 years old
- •Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
- •Patients provided on informed consent
排除标准
- •Individuals with a history of increased bleeding tendencies or hematologic disorders
- •Presented with refractory cardiogenic shock
- •Individuals with a history of stent thrombosis
- •Expected life expectancy of less than 1 year
- •Left ventricular ejection fraction (LVEF) ≥ 20%
- •Women who are breastfeeding, pregnant, or planning to become pregnant
- •Deemed unsuitable for participation by the investigator
- •Patients unwilling to participate in the clinical trial
结局指标
主要结局
Rate of target vessel failure (TVF)
时间窗: 1-year
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
次要结局
- Rate of any myocardial infarction (MI)(1-year)
- Rate of clinically-driven target vessel revascularization (TVR)(1-year)
- Rate of all-cause mortality(1-year)
- Rate of any revascularization(1-year)
- Rate of stent thrombosis (acute, subacute, late, very late)(1-year)
- Rate of BARC-defined bleeding(1-year)
研究者
Kang Dong Oh
Assistant Professor
Korea University Guro Hospital