NCT01845311已完成不适用
RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
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
- •Patient has evidence of myocardial ischemia or a positive functional study
- •Patient has a normal CK-MB
- •Target lesion has a visually estimated stenosis of ≥50% and <100%
- •Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm
- •Target lesion length must be ≤ 14mm
排除标准
- •Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure
- •Patient has a left ventricular ejection fraction < 30%
- •Patient has unprotected lest main coronary disease with ≥50% stenosis
- •The target vessel is totally occluded (TIMI Flow 0 or 1)
- •Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
- •Target lesion is located within a bypass graft
- •Target lesion has possible or definite thrombus
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 12 Months
Major Adverse Cardiac Events (MACE)
时间窗: 6 Months
Late Lumen Loss
时间窗: 9 Months
次要结局
- TVF(12, 24, 36, 48 & 60 Month)
- QCA derived parameters(9 Months)
- Major Adverse Coronary Events(24, 36, 48 & 60 Months)
- Clinical Procedural Success(30 Days)
- TLR(12,24,36,48 & 60 Months)
- TVR(12,24,36,48 & 60 Months)
- Acute Procedural Success(Day 0)
- Acute Technical Success(Day 0)
研究者
研究点 (3)
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