NCT02044666已完成不适用
Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Frequency and types of adverse events
研究概览
简要总结
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
- •Patient is unable to be treated by endovascular or surgical means
排除标准
- •Patient is pregnant or breastfeeding
- •Patient has had a previous surgery within 30 days of the study procedure
- •Patient has a planned surgical or interventional procedure within 30 days after the study procedure
- •Patient has a life expectancy of less than 1 year
- •Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
- •Additional restrictions as specified in the protocol
结局指标
主要结局
Frequency and types of adverse events
时间窗: 180 days
次要结局
未报告次要终点
研究者
研究点 (2)
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