NCT00222196已完成不适用
Oslo Balloon Angioplasty Versus Conservative Treatment
Ullevaal University Hospital0 个研究点目标入组 200 人开始时间: 2000年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- The patient quality of life.
研究概览
简要总结
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.
The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.
Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
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
- None
入排标准
- 年龄范围
- — 至 75 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age below 75 years
- •Symptoms of intermittent claudication with duration > 3 months
- •ABPI <0.9
- •A two-year follow-up is possible
排除标准
- •Subjective pain-free walking distance > 400m
- •Critical ischemia
- •Previous vascular or endovascular surgery
- •Diabetes ulcer
- •Other physical disability abrogating organised exercise
- •Use of warfarin
- •Mentally unable to give informed consent
- •Renal insufficiency
- •Coagulation disorders Duplex or PTA impossible
结局指标
主要结局
The patient quality of life.
次要结局
- Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
研究者
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