Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Secondary Patency
研究概览
简要总结
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included
排除标准
- •All patients below 21
结局指标
主要结局
Secondary Patency
时间窗: 12 months
Secondary Patency is lost when entire dialysis access circuit is abandoned.
Circuit Access Patency
时间窗: 12 Months
Circuit Access Patency is lost when AVF/AVG is intervened on
Primary Assisted Patency
时间窗: 12 months
Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis
次要结局
未报告次要终点