Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- 6-month target lesion primary patency rate
研究概览
简要总结
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
详细描述
To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AVF has been established, with mature development and at least one successful completion of hemodialysis；
- •AVF has significant hemodynamic abnormalities；
排除标准
- •The target lesion has undergone intervention treatment within 30 days；
- •An intravascular stent has been placed at any location along the vascular pathway；
研究组 & 干预措施
Rapamycin coated balloon dilation catheter for arteriovenous fistula
Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
干预措施: Rapamycin drug balloon angioplasty (Procedure)
Rapamycin coated balloon dilation catheter for arteriovenous fistula
Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
干预措施: Paclitaxel drug balloon angioplasty (Procedure)
Paclitaxel release high-pressure shunt balloon dilation catheter
Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
干预措施: Rapamycin drug balloon angioplasty (Procedure)
Paclitaxel release high-pressure shunt balloon dilation catheter
Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
干预措施: Paclitaxel drug balloon angioplasty (Procedure)
结局指标
主要结局
6-month target lesion primary patency rate
时间窗: 6months
Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
次要结局
- Surgical success rate(7Days)
- Device success rate(The day of operation.)
- Clinical success rate(1year)