NCT07330817尚未招募不适用
ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Technical Success
研究概览
简要总结
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
详细描述
First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form
- •Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.
- •Indications for percutaneous endovascular therapy with diameter stenosis >50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)
- •Target lesion is a resistant de novo or restenotic lesion
- •The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.
排除标准
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
- •Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;
- •Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;
- •Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;
- •Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);
- •AVF has been implanted with a stent.
研究组 & 干预措施
ULTRAVIOLET UHP PTA
Experimental
Percutaneous transluminal angioplasty with ultra-high-pressure balloon
干预措施: PTA balloon (Device)
结局指标
主要结局
Technical Success
时间窗: At the end of the procedure (up to 40 minutes)
Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (\<30%) evaluated by fistulography
Freedom from procedure-related complications after 1 month
时间窗: 1 month
freedom from adverse events related to the procedure in 1 month follow up period
次要结局
- Acute Device Success(At the end of the procedure (up to 40 minutes))
- Clinical Success(At the end of the procedure (up to 40 minutes))
- Procedural Surgery success(At the end of hospitalization (assessed up to 5 days))
- Target Lesion Primary Patency(1 month)
- Freedom from target lesion revascularization(1 month)
- Major Adverse Events (MAE)(1 month)
- Dialysis Circuit Patency(1 month)
研究者
研究点 (1)
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