Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- target vessel failure (TVF) at 12 months
研究概览
简要总结
Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.
详细描述
This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.
All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for DCB treatment
排除标准
- •Pregnancy
- •Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- •Expected life less than 12 months
- •Cardiac shock
结局指标
主要结局
target vessel failure (TVF) at 12 months
时间窗: 12 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.
次要结局
- Bleeding at 12 months(12 months)
- Parameter by quantitative coronary angiography at 7 months(7 months)
- Bailout drug-eluting stents (DES) implantation rate(During procedure)
研究者
Junjie Zhang
Vice chief of the department of cardiology
Nanjing First Hospital, Nanjing Medical University