Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 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 Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.
详细描述
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.
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
- 未提供
排除标准
- 未提供
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
- 12-month Limb Salvage Rate(12 months)
- Major Adverse Events at 12-month Post Procedure(12 months)
- Technical success rate(1 day)
- freedom from clinically-driven TLR rate(12 months)