An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
研究概览
简要总结
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
详细描述
This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
- •Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
- •Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
- •Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
排除标准
- •Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
- •Occlusion not penetrable by the infusion guide wire.
- •Known or suspected allergy to contrast agents or heparin sodium.
- •Active bleeding or known hemorrhagic diathesis.
- •Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
研究组 & 干预措施
1
干预措施: Microplasmin (Drug)
2
干预措施: Microplasmin (Drug)
3
干预措施: Microplasmin (Drug)
4a
干预措施: Microplasmin (Drug)
4b
干预措施: Microplasmin (Drug)
结局指标
主要结局
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
时间窗: at 4 hours or less (if study drug administration is terminated prior to 4 hours).
次要结局
- Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)(At 4 hours or less (if study drug administration is terminated prior to 4 hours).)