An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
研究概览
简要总结
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
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
- Double
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
- •Male or non-pregnant female patient minimum 18 years of age
- •No significant (>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
- •Target lesion is 18mm in length (visual estimate);
- •Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
- •Target lesion stenosis is >50% and <100% (visual estimate);
排除标准
- •A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- •Ejection fraction 30%;
- •Stent placement of target lesion covers a side branch >2.0mm in diameter;
结局指标
主要结局
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
时间窗: four-months and twelve-months post-procedure
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
时间窗: four-months and twelve months post-procedure
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
时间窗: four-months and twelve-months post-procedure
Four and twelve month target vessel failure (TVF).
时间窗: Four and twelve month
次要结局
未报告次要终点