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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 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
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
- Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.(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 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)
- 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)
- Limbs-salvage rate(1 year)
研究者
研究点 (2)
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