The e-SELECT Registry a MULTICENTER POST-MARKET SURVEILLANCE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15,000
- 试验地点
- 2
- 主要终点
- acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)
研究概览
简要总结
This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.
详细描述
The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure;
- •Males and females;
排除标准
- 未提供
结局指标
主要结局
acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)
时间窗: 1, 6, 12, 24 and 36 months
次要结局
未报告次要终点
