NCT03350542已完成3 期
EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Target Lesion Failure Rate at 12-months
研究概览
简要总结
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
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 Rate at 12-months
时间窗: 12-month
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
次要结局
- All Death or MI Rate(12 months)
- Periprocedural Technical Success Rate(Day 1 (periprocedural))
- Target Lesion Revascularization (TLR) Rate at 12 Months(12 months)
- Target Vessel Revascularization (TVR) Rate at 12 Months.(12 months)
- Cardiac Death or MI Rate(12 months)
- Target Vessel Failure (TVF) Rate at 12 Months(12 months)
- MI (Q-wave and Non-Q-wave) Rate(12 months)
- Cardiac Death Rate(12 months)
- Non-cardiac Death Rate(12 months)
- All Death Rate(12 months)
- All Death/MI/TVR Rate(12 months)
- Stent Thrombosis Rate(12 months)
- Periprocedural Clinical Procedural Success Rate(12 months)
研究者
研究点 (28)
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