NCT00496041已完成不适用
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.
研究概览
简要总结
This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
- •New TASC (2007) A, B, or C lesions
- •Vessel diameter between 4.5 and 6.5 cm
- •Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- •At least 1 outflow vessel down to the ankle
- •Signed informed consent
- •> Age 50, life expectancy > 1 year
- •Capable of concluding the necessary follow-up visits
排除标准
- •Refusal to participate in the study
- •Acute ischemia
- •Inflow lesions > 50%, not successfully corrected before the procedure
- •Combination with other treatment with the exception of treatment to improve the inflow
研究组 & 干预措施
Smart Stent in the Superficial Femoral Artery .
Experimental
干预措施: Registry (Procedure)
结局指标
主要结局
Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.
时间窗: 1 year
次要结局
- Limbs-salvage rate(1 year)
- Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)(1 year)
- Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA.(1 year)
- Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.(1 year)
- Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion(1 year)
研究者
研究点 (1)
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