Oslo Balloon Angioplasty Versus Conservative Treatment
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
研究概览
研究类型
注册
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age below 75 years
- Symptoms of intermittent claudication with duration > 3 months
- ABPI <0.9
- A two-year follow-up is possible
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
The patient quality of life.
|
次要结果测量
结果测量 |
|---|
|
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
|
合作者和调查者
调查人员
- 首席研究员：Marthe Nylaende, MD、Aker and Ullevål University Hospitals, Oslo, Norway
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
lifestyle, PTA的临床试验
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Shanghai 10th People's HospitalThe First Affiliated Hospital with Nanjing Medical University未知
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Caritasklinik St. Theresia未知
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Biotronik AG完全的动脉硬化 | 动脉粥样硬化 | 外周动脉疾病 | 血管疾病比利时, 奥地利, 德国