NCT05088083Unknown不适用
Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Zhejiang Zylox Medical Device Co., Ltd.0 个研究点目标入组 143 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 143
- 主要终点
- primary patency of target lesion in 6 months
研究概览
简要总结
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
研究组 & 干预措施
DCB Treatment Group
Experimental
Subjects treated with DCB
干预措施: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon (Device)
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) PSVR\< 2.4
次要结局
- Device Success(Time of procedure)
- Clinical Success(From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.)
- Procedural Success(2 weeks)
研究者
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