NCT00922337已完成不适用
A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InspireMD
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Major Cardiac Adverse Events rate (MACE)
研究概览
简要总结
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System
详细描述
A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a "real world" patient population requiring stent implantation.
The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient is > 18 years of age
- •The patient has consented to participate by signing the "Patient Informed Consent Form"
- •Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
- •Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System
- •The patient is willing and able to cooperate with registry procedures and required follow up
排除标准
- •Heavily calcified target lesions
- •Target lesions with side branch bigger then 2.5mm
- •Target lesions which are distal to newly stented lesion (less than 1 month).
- •Women with known pregnancy
- •Current medical condition with a life expectancy of less than 12 months
- •Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation
结局指标
主要结局
Major Cardiac Adverse Events rate (MACE)
时间窗: 1 month
次要结局
- Lesion success rate(1 day)
- Major Cardiac Adverse Events rate (MACE)(6 months)
- Bleeding complications(6 months)
- Stent thrombosis rate(6 months)
- Any death(6 months)
研究者
研究点 (2)
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