ACTRN12610000771055尚未招募未知
In patients with infrainguinal arterial disease, can the Chocolate Balloon Catheter be used safely and effectively for ballon dilatation during percutaneous transluminal revascularization procedures?
Quattro Vascular Pte Ltd0 个研究点目标入组 50 人开始时间: 2010年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Intermittent claudication or critical limb ischemia (Rutherford 2-5)
- •De novo or restenotic stenosis (=50%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries
- •Reference vessel diameter 2.0-6.0 mm
- •Lesion length =150mm
- •Lesion must be successfully crossed with a guidewire
排除标准
- •Acute limb ischemia
- •Non-atherosclerotic disease (e.g. embolism, Buerger's disease, vasculitis)
- •Patient requires any concomitant percutaneous endovascular procedure in other vasculature e.g. renal, coronary, carotid, etc.
- •Myocardial infarction or stroke within 30 days prior to the procedure
- •Any planned surgical intervention/procedure within 30 days of the study procedure
- •In-stent restenosis proximal to or in the target lesion
- •Target lesion distal to a newly implanted stent
研究者
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