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临床试验/NCT00438919
NCT00438919已完成4 期

The e-SELECT Registry a MULTICENTER POST-MARKET SURVEILLANCE

Cordis Corporation2 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2006年5月最近更新:
适应症

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

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

研究者

申办方类型
Industry

研究点 (2)

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