Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Freedom from vascular or endovascular arterial intervention below the knee of the study leg
研究概览
简要总结
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The investigator for this study is the person that will be performing the injections throughout the study and will know the participant's treatment (TNC or saline). The investigator that is aware of the participant's treatment will not be performing the follow-up visits.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
- •Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization
排除标准
- •Simultaneously participating in another investigational study (e.g., drug or device)
- •Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
- •Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
- •Endovascular intervention within the past 30 days
- •Current dialysis, or expected to need dialysis within the next 12 months
- •Previous above the ankle amputation in the study leg
结局指标
主要结局
Freedom from vascular or endovascular arterial intervention below the knee of the study leg
时间窗: 12 months
Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
Death
时间窗: 12 months
Percent of patients that exit due to death
Freedom from major amputation of the study leg
时间窗: 12 months
Percent of patients that have any amputation above the ankle of the study leg
次要结局
未报告次要终点