NCT02840786已完成不适用
Occlusive Disease of Lower Extremity
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
- 221
- 试验地点
- 1
- 主要终点
- 12-month Primary Patency Rate
研究概览
简要总结
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
详细描述
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). They were excluded if they had one or more of the following:
- •Acute or subacute lower limb ischemia;
- •Severe calcification lesions;
- •Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization
- •untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root;
- •Previously lower extremity intervention or surgical graft artery bypass;
- •Severe renal insufficiency, creatinine level greater than 2.5 mg/dL;
- •The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications;
- •Patients with immune system diseases or malignant tumours;
- •ongoing active infection
- •decompensated congestive heart failure or acute coronary syndrome;
- •Unwillingness to return for future follow-up visits
排除标准
- 未提供
研究组 & 干预措施
Intervention: Stents
Active Comparator
Stents group
干预措施: balloon and Stent (Device)
Intervention: Atherectomy
Active Comparator
directional atherectomy group
干预措施: plaque excision system (Device)
结局指标
主要结局
12-month Primary Patency Rate
时间窗: 12 months
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
次要结局
- Technical success(1 day)
- freedom from clinically-driven TLR(12 months)
- Major Adverse Events at 12-month Post Procedure(12 months)
- 12-month Limb Salvage Rate(12 months)
研究者
研究点 (1)
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