NCT02145845已完成不适用
Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Frequency and types of adverse events after treatment with the Cook Injectable SIS
研究概览
简要总结
This study is intended to collect safety and effectiveness data on the Cook Injectable 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
- •Diagnosis of critical limb ischemia
- •Rutherford 4-5 or Leriche-Fontaine IIIB
- •Patient unable to be treated by endovascular or surgical means
排除标准
- •Patient's age is <21
- •Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
- •Patient has had a previous surgery, within 30 days of the study procedure
- •Patient has any planned surgical or interventional procedure within 30 days after the study procedure
- •Patient has a life expectancy 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 Clinical Investigation Plan
研究组 & 干预措施
Treatment
Experimental
Injectable SIS
干预措施: Injectable SIS (Device)
结局指标
主要结局
Frequency and types of adverse events after treatment with the Cook Injectable SIS
时间窗: 180 days
次要结局
未报告次要终点
研究者
研究点 (1)
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