NCT04234893已完成不适用
A Registry Study of Bingo Drug-Coated Balloon in Real World
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.
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
- •Age 18 or older, regardless of gender;
- •Patients suitable for PCI with paclitaxel drug-coated balloon;
- •Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.
排除标准
- •General exclusion criteria
- •Contraindications to PCI;
- •In-stent restenosis;
- •Life expectation less than 1 year;
- •Patients not suitable for enrollment considered by investigator.
- •Angiographic exclusion criteria:
- •Target lesion with the following conditions after pre-dilatation:
- •Residual stenosis larger than 30% ;
- •TIMI flow grade less than 3;
- •Type C-F dissection (NHLBI grade).
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 12 months
a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization
次要结局
- clinical success(immediately after the procedure， up to 7 days)
- device success(immediately after the procedure)
- lesion success(immediately after the procedure)
- Target lesion failure(1, 6, 12 and 24 months)
- Target lesion thrombosis(immediately after the procedure， up to 24 months)
- rate of Target lesion revascularization(1, 6, 12 and 24 months)
- Acute vessel closure(during the procedure and up to 24 hours)
研究者
研究点 (1)
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