NCT01605721Unknown4 期
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF) rate at 12 months
研究概览
简要总结
Objectives:
- To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
- To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent
Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM
Study period
- Patient enrollment: 2011.05 ~ 2012.04
- End of follow-up period: 2015. 02 (3 years of follow-up)
Primary endpoint
: Target Lesion Failure (TLF) rate at 12 months
Secondary endpoint:
- In-stent & In-segment Late Loss at 9 months
- Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
- Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
- Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
- Composite rate of cardiac death and any MI up to 3 years
- Composite rate of all death and any MI up to 3 years
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
- Procedural success up to 1 day
- Angiographic success up to 1 day
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Target Lesion Failure (TLF) rate at 12 months
时间窗: 12 months
次要结局
- angiographic success up to 1 day(1 day)
- In-stent & In-segment Late Loss at 9 months(9 months)
- Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)(24 hours, 30 days, up to 3 years)
- Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years(30 days, 9 months, 1 year, up to 3 years)
- Composite rate of cardiac death and any MI up to 3 years(up to 3 years)
- Composite rate of all death and any MI up to 3 years(up to 3 years)
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years(up to 3 years)
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years(up to 3 years)
- procedural success up to 1 day(1 day)
研究者
Hyo-Soo Kim
MD PhD
Seoul National University Hospital
研究点 (1)
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