Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
研究概览
简要总结
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.
The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.
详细描述
Introduction:
Half of patients with hemodialysis vascular access will present at least one episode of dysfunction within 1 year after creation, mainly due to intimal hyperplasia and stenosis. Paclitaxel is an antiproliferative drug that can limit intimal hyperplasia in vessels. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
Main objective:
To show that the use of Paclitaxel-coated balloons to treat stenosis of vascular accesses will improve post-interventional patency and reduce numbers and days of hospitalization for access maintenance in hemodialysis vascular access.
Hypothesis:
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 must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
- •Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft)
- •Patient must have a dysfunction of its vascular access, defined by :
- •dialysis sessions last >4 hours
- •and/or access flow < 400ml/min for fistulae and <600ml for grafts, or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan,
- •and/or dialysis recirculation
- •and/or thrill not perceived
- •and/or pulsatile vascular access
- •and/or bleeding or increased bleeding time after puncture
- •A stenosis >50% of the venous line must be diagnosed on the initial fistulogram
- •A successful plain balloon angioplasty of the stenosis, defined by residual stenosis <30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion.
排除标准
- •Pregnant or nursing woman, or plans to become pregnant during the study.
- •Patient has hyperkalemia >6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion
- •Vascular access has in-stent restenosis
- •Initial fistulogram shows no stenosis
- •Initial fistulogram shows indication for open surgical intervention
- •Control fistulogram (after plain balloon angioplasty) shows indication for stenting or open surgical intervention
结局指标
主要结局
Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
时间窗: at 12 months
次要结局
- Assisted-primary patency of the vascular access(at 6 and 12 months after treatment)
- Number of reinterventions (endovascular or surgery)(after treatment during the follow-up (at 12 months))
- Primary patency of the vascular access(at 6 months after treatment)
- Days of hospitalization for reinterventions (endovascular or surgery)(after treatment during the follow-up (at 12 months))
- Secondary patency of the vascular access(at 6 and 12 months after treatment)