Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Percentage diameter stenosis
研究概览
简要总结
The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.
详细描述
The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.
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 (Outcomes Assessor)
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
- •Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
排除标准
- •Acute ischemia and/or acute thrombosis of the SFA
- •Untreated ipsilateral iliac artery stenosis >70%
- •Not at least one vessel run-off
- •Popliteal involvement with stenosis >70%
- •Severe renal insufficiency (GFR <30 ml/min/m2)
- •Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial.
- •Patient's inability to fully cooperate with the study protocol.
研究组 & 干预措施
conventional PTA
In stent restenosis is treated with PTA using a conventional balloon.
干预措施: PTA (Device)
conventional PTA
In stent restenosis is treated with PTA using a conventional balloon.
干预措施: Percutaneous Transluminal Angioplasty (PTA) (Procedure)
PTA with PEB
In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
干预措施: PTA with PEB (Device)
PTA with PEB
In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
干预措施: Percutaneous Transluminal Angioplasty (PTA) (Procedure)
结局指标
主要结局
Percentage diameter stenosis
时间窗: 6 months
次要结局
- Percentage diameter stenosis in duplex ultrasound(6 and 24 months)
- Time to onset of any of MAPE(3-24 months)
- Binary restenosis rate(6 months)
- All-cause mortality(6 and 24 months)
- Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)(6 Months)