SIRolimus-coated Versus Plain Old Balloon Angioplasty in Upper Extremity Arteriovenous Shunt Stenosis - the SIR-POBA Shunt Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis
研究概览
简要总结
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an arteriovenous shunt stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment modality.
详细描述
This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the shunt up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.
The shunts are checked for functionality as part of the dialysis required three times a week and presented to our department beforehand in need. This saves chronically ill patients the additional waiting time in hospital outpatient departments.
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
- 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
- •Age at least 18 years
- •Informed consent with signature
- •Maturated shunt, defined as already in use for two weeks
- •Shunt stenosis in need of intervention
排除标准
- •Pregnant or breastfeeding women
- •Active infection or sepsis
- •Incapacitated patients
- •Lesions in the affected stenosis already pretreated by stenting in the same area shunt.
- •Patients currently participating in another study
- •Central venous stenosis worthy of treatment
- •intolerance to sirolimus
- •coagulopathy
- •radiotherapy
- •patients on immunosuppressive therapy
- •use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).
结局指标
主要结局
Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis
时间窗: 2 years
The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt.
次要结局
未报告次要终点
研究者
Manuela Pilz
Senior physician
Paracelsus Medical University