NCT00428129终止2 期
An Open Label Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
研究概览
简要总结
A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: microplasmin (Drug)
结局指标
主要结局
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
时间窗: During intervention procedure
次要结局
- Grade of lysis(Upon completion of procedure)
- Limb patency(Baseline, 48h post procedure, Day-7 and Day-30)
- Target limb reintervention(Day-7 and Day-30)
- Clinical outcomes(Baseline, 48h post procedure, Day-7 and Day-30)
研究者
研究点 (1)
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