NCT02979236Unknown不适用
Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry
UOSD Emodinamica Diagnostica e Interventistica8 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction
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
- •Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
排除标准
- •Cardiogenic shock
- •Multiple lesions requiring stenting in the target vessel.
- •Highly calcified lesions or excessive tortuosity at target lesion site.
- •Intrastent pathology.
- •Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines.
- •Female subjects of childbearing potential known to be pregnant.
- •Co-morbidities with life expectancy less than 1 year
- •Patient unable to provide written informed consent.
- •Known allergies to stent component.
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months post procedure
target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG).
次要结局
- Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay(during the hospitalization, an average of 6 days)
- Death from any cause(12 months post procedure)
- Target lesion failure at 30-day post-procedure(30 day post procedure)
- Stent thrombosis rate at 30-day and 12-months after the procedure(30 days post procedure and 12 months post procedure)
研究者
Livio Giuliani
MD PhD
UOSD Emodinamica Diagnostica e Interventistica
研究点 (8)
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