NCT03842813Unknown不适用
Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,030
- 试验地点
- 22
- 主要终点
- The primary endpoint is Target Lesion Failure (TLF) rate at 1 year
研究概览
简要总结
The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.
As routine care, each patient will be followed until 12 months after stent implantation.
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
- •≥18 years old,
- •patient informed and agreed to participate,
- •patient with one or more lesions treated with one or more coronary stent CRE8,
- •patient with a diabete insulin dependent or non-insulin dependant.
排除标准
- •pregnant or breast-feading women,
- •patient who refused to participate,
- •patient with another lesion treated during the same intervention with a balloon alone or with another stent
结局指标
主要结局
The primary endpoint is Target Lesion Failure (TLF) rate at 1 year
时间窗: 1 year post implantation
The TLF is defined as cardiac deaths, heart attack in relation with the target vessel or revascularization of the target lesion. If a patient has at least one of these events, he will be considered as TLF.
次要结局
- Stent thrombosis at 1 year(1 year)
- Major Adverse Cardiac Events (MACE) at 1 year(1 year)
- Non cardiac deaths at 1 year(1 year)
- Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy(1 year)
- Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy(1 year)
- Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy(1 year)
研究者
研究点 (22)
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