NCT00134277已完成不适用
Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
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
- 35
- 试验地点
- 1
- 主要终点
- Primary patency after 6 months
研究概览
简要总结
This study is a comparison of different medical devices for infragenual dilatation.
详细描述
Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- •Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
排除标准
- •Acute ischemia
- •Multisegmentaric damage above the knee
- •Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) > 30, white blood cell (WBC) > 25,000
- •Acute myocardial infarction (AMI) during the last 14 days
- •Operative contraindication
- •Life expectancy < 2 years
- •Blue toe syndrome (micro-embolisation)
研究组 & 干预措施
Infragenual dilatation
Placebo Comparator
干预措施: Infragenual dilatation (Procedure)
Infragenual dilatation with stenting
Active Comparator
干预措施: Infragenual dilatation with stenting (Procedure)
Infragenual dilatation with cutting balloon
Active Comparator
干预措施: Infragenual dilatation with cutting balloon (Procedure)
Laser therapy
Active Comparator
干预措施: Laser therapy (Procedure)
结局指标
主要结局
Primary patency after 6 months
时间窗: After 6 months
次要结局
- Proving the superiority or non-superiority of one treatment procedure to another treatment procedure(After 6 months.)
研究者
研究点 (1)
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