NL-OMON50453招募中不适用
Randomized comparison of FemORal drug-Eluting balloons and Stents (FOREST TRIAL) - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease - FOREST trial
Stichting DEAll, wetenschappelijke stichting ter bevordering van vasculair wetenschappelijk onderzoek0 个研究点目标入组 254 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 254
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >= 18 years
- •Patients must be willing to sign an informed consent form
- •Rutherford-Baker class 2-6
- •At least 1 symptomatic de novo atherosclerotic lesion in the superficial
- •femoral artery and/or popliteal artery, section P1
- •There will be no maximum lesion length
- •Diameter of reference vessel between 4 to 7 mm
- •The lesion should be a stenosis of at least 50% or an occlusion assessed by
- •CT-angiography or MR-angiography or assessed by duplex ultrasound (DUS, peak
- •systolic velocity ratio (PVR) of >2.5)
- •At least 1 patent tibial runoff vessel
- •Successful passage with guide wire
排除标准
- •Life expectancy <= 1 year
- •Restenotic lesions
- •Acute femoro-popliteal occlusion
- •Recurrent stenosis or occlusion
- •Aspirin, Clopidogrel, Heparin or Paclitaxel allergy
研究者
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