NCT06104033招募中不适用
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Bon-Kwon Koo1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The reclassification rate of the treatment strategy
研究概览
简要总结
This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.
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
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 or older
- •Multivessel coronary artery disease patients requiring coronary intervention
- •Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
- •Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
- •Capable of understanding the risks and benefits of participating in the study and providing informed consent
排除标准
- •Incapable of voluntarily providing informed consent
- •Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- •Cardiogenic shock or cardiac arrest patients
- •Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- •Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
- •Patients with severe valvular heart disease requiring open heart surgery
- •Pregnant or lactating women
结局指标
主要结局
The reclassification rate of the treatment strategy
时间窗: At the time of procedure
The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.
次要结局
- Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy(At the time of procedure)
- Target vessel MI excluding periprocedural MI(1 year)
- Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy(At the time of procedure)
- All-cause death(1 year)
- Target vessel MI including periprocedural MI(1 year)
- Cardiovascular death(1 year)
- Non-fatal myocardial infarction (MI)(1 year)
- Clinically indicated target vessel revascularization(1 year)
- Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition(1 year)
- Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization(1 year)
- Any revascularization(1 year)
- Cardiovascular death, target vessel MI, or vessel or stent thrombosis(1 year)
- Major bleeding events (BARC type 2, 3, or 5)(1 year)
- Clinically indicated target lesion revascularization(1 year)
- Cardiovascular death or target vessel MI(1 year)
- All-cause death or non-fatal MI(1 year)
- Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization(1 year)
- All-cause death, non-fatal MI, or clinically indicated target vessel revascularization(1 year)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital
研究点 (1)
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