Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events at 12 months
研究概览
简要总结
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
详细描述
There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •de novo coronary artery disease
排除标准
- •unstable hemodynamics at presentation
- •life expectancy <1 year
结局指标
主要结局
Major adverse cardiac events at 12 months
时间窗: 12 months
Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding \[BARC type 3 to 5\]) at 12 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
次要结局
- Angiographic and clinical outcomes(12, 24, 36 months)
研究者
Eun-Seok Shin
Director
Ulsan Medical Center