Prospective Randomized Trial Comparing Drug Eluting Balloon Versus Conventional Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Restenosis rate
研究概览
简要总结
This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.
详细描述
The cephalic vein constitutes the major outflow conduit for radial- cephalic autogenous accesses and is the sole outflow conduit for brachial- cephalic autogenous accesses. The portion of the cephalic vein that becomes perpendicular in the region of the deltopectoral groove before its confluence with the axillary or subclavian vein,the cephalic arch, is prone to the development of hemodynamically significant stenosis which is usually treated with balloon angioplasty. Unfortunately restenosis due to angioplasty induced intimal hyperplasia is common and periodic repeated angioplasty is necessary to maintain patency.
Paclitaxel is a mitotic inhibitor used in cancer chemotherapy which is used as an antiproliferative agent for the prevention of restenosis (recurrent narrowing) of blood vessels after balloon angioplasty caused by excessive intimal proliferation. It is locally delivered to the wall of the blood vessel during the dilatation using a paclitaxel eluting balloon.
Initial trials with these balloons have shown promising results in peripheral arteries and early encouraging results in dialysis access.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper limb dialysis access fistula
- •Angiographically demonstrated cephalic arch stenosis >50% within 6 months of last angioplasty using a non drug eluting balloon
- •Clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised Kt/V, raised dialysis venous pressure
排除标准
- •Contrast allergy
- •Unable to give informed consent
- •Cephalic arch stent or stent graft
- •Life expectancy less then 6 months
研究组 & 干预措施
Standard balloon angioplasty
Dilatation of stenosis with standard non drug eluting balloon catheter
干预措施: Balloon angioplasty (Bard Dorado) (Device)
Drug eluting balloon angioplasty
Dilatation of stenosis with paclitaxel eluting balloon catheter
干预措施: paclitaxel (Cardionovum Legflow drug eluting balloon) (Drug)
结局指标
主要结局
Restenosis rate
时间窗: 6 months
Incidence of \>50% stenosis at the treatment site
次要结局
- Post intervention lesion patency(Up to 12 months)
研究者
Anthony Verstandig
Dr
Shaare Zedek Medical Center