SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass 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 venous bypass 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 infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.
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 bypass 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.
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
- •Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
- •Venous bypass stenosis requiring intervention
- •Confirmed inflow
- •At least 1 crural outflow vessel
排除标准
- •Pregnant or lactating women
- •Active infection or sepsis
- •Patients currently participating in another clinical trial
- •Unconfirmed inflow
- •Intolerance to sirolimus
- •Coagulopathy
- •Radiotherapy
- •Patients on immunosuppressive therapy
- •Non-dialysis renal insufficiency (eGFR < 45 ml/min/1.73m2)
- •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 venous bypass stenosis
时间窗: 2 years
The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
次要结局
未报告次要终点
研究者
Manuela Pilz
Senior Physician
Paracelsus Medical University