NCT00059657已完成3 期
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM in Conjunction With Peripheral Revascularization for the Treatment of Critical Leg Ischemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 22
- 主要终点
- Reduction in the proportion of subjects who experience a major amputation.
研究概览
简要总结
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
- •Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.
排除标准
- •Subjects with a previous major amputation (at or above ankle)
- •Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of < 20 cc/min, or receiving chronic hemodialysis therapy.
结局指标
主要结局
Reduction in the proportion of subjects who experience a major amputation.
Reduction in proportion of subjects who die within 6 months from treatment initiation.
次要结局
- Improvement in quality of life.
- Improvement in neuropathy.
- Reduction in major amputation rate only.
- Improvement in graft patency of index operation.
- Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
- Improvement in complete ulcer healing.
- Improvement in pain at rest.
- Improvement in hemodynamic measurements.
研究者
研究点 (22)
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