Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 8
- 主要终点
- Freedom from target lesion revascularization
研究概览
简要总结
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.
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
- Double (Participant, Outcomes Assessor)
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
- •Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
- •Patient diagnosed with AVF stenosis by clinical and radiological criteria
- •Sign informed consent
排除标准
- •Pregnant or breastfeeding
- •Patients with AVF stenosis not could be treated with PTA catheter
- •Paclitaxel allergy
- •Iodinated contrast allergy
- •Local or systemic active infection
- •Life expectancy less than 12 moths
研究组 & 干预措施
Paclitaxel-releasing PTA balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
干预措施: Paclitaxel-releasing PTA balloon catheter (Device)
PTA Balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
干预措施: PTA balloon catheter (Device)
结局指标
主要结局
Freedom from target lesion revascularization
时间窗: 12 months
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
次要结局
未报告次要终点