Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.
详细描述
In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
- •Patients with AVF or AVG
- •Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm
排除标准
- •Fistula or graft or vessel diameter < 3 mm and > 12 mm
- •History of severe allergic reaction to contrast media
- •Intolerance to aspirin and/or clopidogrel
- •Systemic coagulopathy or hypercoagulation disorders
结局指标
主要结局
Technical success
时间窗: 1 minute after the final balloon angioplasty
Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
Primary patency
时间窗: 1 year
Angiographic visualization of a lesion with \<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.
次要结局
- Secondary patency(1 year)
- Target lesion re-intervention (TLR)-free interval(1 year)
- Major complications rates(Periprocedural and up to 1 year)
- Minor complications rates(Periprocedural and up to 1 year follow-up)
研究者
SIABLIS DIMITRIOS
Professor of Radiology
University of Patras