NL-OMON52244招募中不适用
The impact of optical coherence tomography on the decision-making process of endovascular treatment of femoropopliteal disease - Optimo study
Rijnstate Ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Aged 18 years or older
- •Written informed consent
- •Scheduled endovascular treatment of femoropopliteal stenotic lesions with a
- •Supera or Absolute stent
- •Clinically and hemodynamically stable
排除标准
- •Occluded superficial femoral artery or popliteal artery
- •Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm
- •Severely impaired renal function (eGFR < 30 ml/min), end stage renal disease
- •Cardiac insufficiency (NYHA 3-4)
- •Hypersensitivity to iodinated contrast media
- •BMI > 25 and contralateral approach not possible
- •Minimal lumen diameter of target lesion < 1.5 mm
- •Presence of a hemodynamically significant inflow stenosis in the aorto-iliac
- •tract or the common femoral artery
- •Participating in another trial with an investigational drug or medical device
- •concerning the femoropopliteal tract, interfering with the current study
- •Life expectancy of less than 24 months
- •Woman of child-bearing age not on active birth control
- •Legally incapable
研究者
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