NCT00855478终止4 期
French Post-Marketing Surveillance Survey
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4,080
- 主要终点
- There is no pre-specified endpoint.
研究概览
简要总结
To assess the safety and effecacy of the Cypher stent ™ & Cypher Select ™ in the normal use of medical practices, within the labeled indications.
详细描述
Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with symptomatic ischemic heart disease due to de novo lesions (lesions <30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.
排除标准
- •Patients suffering from coronary heart disease.
- •Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
- •Patients with injuries incompatible with the full inflation of a balloon angioplasty;
- •Transplant patients ;
- •Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;
结局指标
主要结局
There is no pre-specified endpoint.
时间窗: 12 Months
次要结局
未报告次要终点
研究者
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