The Efficacy and Safety of Paclitaxel-eluting Balloons for the Treatment of Below the Knee Peripheral Arterial Disease as Compared to Conventional Balloon Angioplasty: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Restenosis rate
研究概览
简要总结
Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).
详细描述
Over the past decade, percutaneous transluminal angioplasty (PTA) has established its position in the treatment of below the knee arterial occlusive disease with intermittent claudication and/or critical limb ischemia. However, the efficacy of percutaneous transluminal angioplasty (PTA) with conventional balloons, is limited by the high 12-month restenosis and target lesion revascularization (TLR) rates. Local delivery of newer anti-proliferative drug via drug-eluting balloons (DEBs) has recently shown promising results in the treatment of femoropopliteal disease, and in the BTK area, a reduction in 3-month binary restenosis has been observed compared with historical controls treated with PTA. Drug eluting balloon has three potential advantages: (1) homogenous drug transfer to the vessel wall; (2) highest drug concentrations at the vessel wall at the time of injury; and (3) absence of a stent or delivery polymer.
This study sought to investigate the long-term efficacy and safety of new drug (Paclitaxel)-eluting balloons (DEB) for the treatment of below the knee peripheral arterial disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Peripheral vascular disease with or without diabetes.
- •Rutherford class 2-
- •Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
- •Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
- •Written informed consent signed by the patients or representatives
排除标准
- •Previous bypass surgery or stent placement at the ipsilateral lower limb
- •History of intolerance to antiplatelet therapy, heparin, or contrast media.
- •Bleeding diathesis;
- •Active systemic bacterial infection;
- •Severely impaired renal function (serum creatinine level > 2.5 mg/dL.
- •Expected survival time of less than 24 months
研究组 & 干预措施
Conventional balloon angioplasty
Conventional balloon angioplasty
干预措施: Conventional balloon angioplasty (Device)
Drug eluting balloon angioplasty
Paclitaxel coated balloon angioplasty
干预措施: Drug eluting balloon angioplasty (Device)
结局指标
主要结局
Restenosis rate
时间窗: 12 months
The primary study endpoint was the occurrence of \> 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA).
Peak systolic velocity ratio
时间窗: 12 months
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography was the end point of the study for the patient who did not undergo angiography after 12 months.
次要结局
- Rutherford scale(Immediately after procedure)
- ABI value(Immediately after procedure)
- Residual stenosis(Immediately after procedure)
研究者
Maoquan Li
Prof. Dr.Li
Shanghai 10th People's Hospital