SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
研究概览
简要总结
Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.
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
- •Age 18-90 years
- •Patient is able and willing to provide written informed consent
- •A Dialysis Access that has performed at least 1 successful dialysis session
- •Stenosis >50% at the outflow vein (by visual estimation) with clinical circuit dysfunction
- •Lesion of ≤7mm in diameter
- •Lesion of up to the 70mm in length
排除标准
- •Life expectancy <1year
- •Lower extremity AVG
- •Infected AVG
- •Uncontrolled systemic infection
- •Aneurysm or pseudoaneurysm in proposed target lesion
- •Presence of previous CS or BMS
- •≥2 lesions present within the circuit
- •Unable to perform protocol prescribed pre-dilation of the lesion
- •Patient is female and is pregnant, or planning to become pregnant during the course of the study.
结局指标
主要结局
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
时间窗: 30 days
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
Primary Patency of the treated lesion at 6 months post-intervention.
时间窗: 6 months
Primary patency: Defined as uninterrupted patency after the initial intervention with regular ongoing dialysis until symptomatic recurrent stenosis of the dialysis circuit, or thrombosis, mandating repeat treatment, or further surgical intervention of the access circuit or eventual failure/abandonment of the circuit with creation of alternative access for dialysis. This endpoint will be analysed cumulatively at 6 months and with time-to-event methods (e.g. Kaplan Meier) on extended follow-up period to 2 years.
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
时间窗: 30 days
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
次要结局
- Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.(6 months)
- Device Success(During Procedure)
- Late lumen loss(6 months)
- Anatomic success(Immediately after angioplasty)
- Clinical Success(6 months)
- Binary Vessel Restenosis(6 months)