NCT00231244已完成3 期
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years.
研究概览
简要总结
The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or non-pregnant female patient minimum 18 years of age
- •There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
- •Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
- •Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;
排除标准
- •There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
- •The study target lesion has definite or possible thrombus present by angiographic criteria.
结局指标
主要结局
The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years.
时间窗: 30 days, 6mo, 12mo, 2, 3, 4, and 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
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