跳至主要内容
临床试验/NCT03366727
NCT03366727已完成不适用

Drug-eluting Balloon for Arteriovenous Fistula in China

Acotec Scientific Co., Ltd13 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
244
试验地点
13
主要终点
primary patency of target lesion in 6 months

研究概览

简要总结

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

详细描述

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

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 (Outcomes Assessor)

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

入选标准

  • Age during 18-85 years old
  • Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
  • Venous stenosis of the AV fistula
  • target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these:1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
  • the length of target lesion ≤100mm
  • Patient able to give informed consent
  • residual stenosis ≤30% after predilation

排除标准

  • Women who are breastfeeding, pregnant or are intending to become pregnant
  • AVF located at lower limbs
  • two or more than two stenosis at the target vessel.
  • Obstruction of central venous return
  • AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
  • vascular access has surgery in 30 days or intending to undergo a surgery
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • Patients undergoing immunotherapy or suspected / confirmed vasculitis
  • Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
  • Vascular access infection or systemic active infection
  • patients's life expectancy is less than 12 months
  • Renal transplantation has been planned or converted to peritoneal dialysis
  • Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
  • involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

结局指标

主要结局

primary patency of target lesion in 6 months

时间窗: 6 months

Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated

次要结局

  • primary patency of target lesion in 12 months(12 months)
  • number of reinterventions(12 months)
  • device success(during the procedure)
  • clinical success(5 days)
  • Procedural Success(2 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (13)

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