NCT01260870终止2 期
European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia
Bayer6 个研究点 分布在 4 个国家目标入组 44 人开始时间: 2011年8月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Evaluate procedural safety
研究概览
简要总结
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Subjects with CLI
排除标准
- •Participation in another research trial
- •Medical conditions the study doctor will assess
研究组 & 干预措施
Cotavance
Experimental
干预措施: Cotavance Paclitaxel Coated Balloon (Device)
Standard balloon angioplasty
Active Comparator
POBA
干预措施: Standard balloon angioplasty (Device)
结局指标
主要结局
Evaluate procedural safety
时间窗: 30 days
次要结局
- Identify and characterize therapeutic and functional endpoint assessments(5 years)
研究者
研究点 (6)
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