NCT01356888Unknown不适用
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- Biotronik AG
- 入组人数
- 452
- 试验地点
- 24
- 主要终点
- Late Lumen Loss
研究概览
简要总结
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Subject has provided a written informed consent
- •Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
- •The target lesion length is ≤ 26 mm
- •The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm
排除标准
- •Evidence of myocardial infarction within 72 hours prior to index procedure
- •Unprotected left main coronary artery disease (stenosis >50%)
- •Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
- •Target lesion involves a side branch > 2.0 mm in diameter
- •Heavily calcified lesion
- •Target lesion is located in or supplied by an arterial or venous bypass graft
研究组 & 干预措施
Abbott Laboratories - Xience Prime DES
Active Comparator
干预措施: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) (Device)
Biotronik - Orsiro DES
Experimental
干预措施: Percutaneous Coronary Intervention (Orsiro DES) (Device)
结局指标
主要结局
Late Lumen Loss
时间窗: 9 months post index procedure
次要结局
未报告次要终点
研究者
研究点 (24)
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