Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Stenosis or occlusion in treated vascular access
研究概览
简要总结
Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes.
Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.
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
- Single (Participant)
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
- •Active dialysis with a mature upper extremity dysfunctional haemodialysis access
- •Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
- •Adult (>18 years)
- •Target vessel diameter 3-8mm
排除标准
- •Thrombosed access
- •In stent restenosis
- •Pregnancy
- •Age less than 18 years
研究组 & 干预措施
Drug Eluting Balloon (DEB)
Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology.
Drug: Paclitaxel (PTX). Name of Device: Advance PTX
干预措施: Advance PTX (Device)
Drug Eluting Balloon (DEB)
Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology.
Drug: Paclitaxel (PTX). Name of Device: Advance PTX
干预措施: Paclitaxel (PTX) (Drug)
Plain Old Balloon Angioplasty (POBA)
Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty.
Drug: None. Name of Device: Advance LP (Low Profile)
干预措施: Advance LP (Low Profile) (Device)
结局指标
主要结局
Stenosis or occlusion in treated vascular access
时间窗: 12 months
Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis \>50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)
Freedom from restenosis in treated vascular access
时间窗: 12 months
Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
时间窗: 12 months
Functional status of vascular access.
次要结局
未报告次要终点
研究者
Torbjorn Fransson
Consultant Vascular Surgeon
Skane University Hospital