NCT04285073Unknown不适用
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.
详细描述
- Evaluation of safety Primary outcome: all adverse events occurring in the subject
- Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female between the ages of 20 and 80
- •Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
- •Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
- •Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted
排除标准
- •Pregnant or lactating women
- •Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
- •Patients with life expectancy less than 12 months
- •Patients expected to receive a kidney transplant during the trial
- •Patients with current or suspected infection
- •Acute psychiatric problems require treatment
- •Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
- •Patients with coagulation disorder, platelet count <50,000 / Ul
- •Patients with a neutrophil count of less than 1,500 cells / mm3
- •Patients judged to be unable to insert grafts by the operator
结局指标
主要结局
Adverse events
时间窗: Up to 2 years after implantation of AVG
All adverse events occurring in the subject
Primary patency
时间窗: at 6 months after implantation of AVG
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
次要结局
- Secondary patency(Up to 2 years after implantation of AVG)
研究者
Kim Dae Joong
professor
Samsung Medical Center
研究点 (2)
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