Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
研究概览
简要总结
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
详细描述
A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with significant multivessel coronary artery disease requiring revascularization
- •Any De novo lesions (reference vessel diameter of 2.25mm~4.0mm) suitable for DCB angioplasty
- •Lesion suitable for intravascular imagings
- •Written informed consent
排除标准
- •Hemodynamically unstable or cardiogenic shock
- •Left main stenotic lesion or graft vessel lesion
- •Visible angiographic thrombus, not resolved by balloon angioplasty
- •Pregnancy or breastfeeding
- •Comorbidities with life expectancy < 12 months
- •Severe coronary calcification or tortuosity, hindering timely DCB delivery
结局指标
主要结局
Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
时间窗: 6~9 month
ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.
次要结局
- Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.(6~9 month)
研究者
Sunwon Kim
Sunwon Kim, MD, PhD, Associate professor
Korea University Ansan Hospital