A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- patent rate in percentage after PTA
研究概览
简要总结
The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 90 years
- •Patients under hemodialysis via prosthetic arteriovenous graft in the arm
- •Vascular access was created for more than 30 days and used at least one successful session
- •Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
- •Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.
- •Reference diameter of venous anastomosis within 7 mm
排除标准
- •Patient could not write informed consent
- •Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular
- •Current or scheduled enrollment in other, conflicting studies.
- •Acute thrombosis in the past 3 months
- •Central venous stenosis
- •Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
- •A blood coagulation disorder
- •Sepsis or infected arteriovenous access graft
- •A contraindication to the use of contrast medium
研究组 & 干预措施
Drug-Eluting Balloon
PTA with DEB at venous anastomotic stenosis of AVG
干预措施: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy) (Device)
Plain Balloon
PTA with PCB at venous anastomotic stenosis of AVG
干预措施: Plain Balloon (Device)
结局指标
主要结局
patent rate in percentage after PTA
时间窗: 1 year
Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.
次要结局
- The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)(1 year)
- Time interval of patent AVG after PTA(1 year)
- The rate of AVG failure at 6 months and 12 months(1 year)
- The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)(1 year)
- Change of AVG flow in liter per minute(1 year)
- Change of AVG pressure in mmHg(1 year)