BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 14
- 主要终点
- Freedom from in-stent restenosis at 1 year
研究概览
简要总结
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1 Enlargement of endovascular therapy indication was based on patient choice for a less invasive technique and evidence based medicine. Consequently, TASC classification of lesions has been modified to reflect increased evidence for endovascular treatment of more extensive femoropopliteal lesions, and indication for endovascular repair has been enlarged to more severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the interventionalists have at their disposal a huge tool box. Evaluation of these tools is crucial to determine the right treatment strategy to avoid further reinterventions and overcosts.
The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee intermediate length femoropopliteal lesions.
From hospitals in Europe (France, Switzerland) we will randomly assign patients with symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Freedom from in-stent restenosis at 1 year
时间窗: 1 year
It was defined by restenosis of \>50% and by a peak systolic velocity index \>2.4 at the target lesion.
次要结局
- residual diameter stenosis(Day 0)
- Secondary sustained clinical improvement(1 month, 12 months and 24 months)
- Primary patency(1 month, 12 months and 24 months)
- Ankle brachial index(1 month, 6 months, 12 months and 24 months)
- Major adverse events(1 month, 12 months and 24 months)
- Limb salvage(1 month, 12 months and 24 months)
- Death(1 month, 12 months and 24 months)
- Target Extremity Revascularization (TER)(1 month, 12 months and 24 months)
- Target lesion revascularization (TLR)(1 month, 12 months and 24 months)
- Stent fracture(1 month, 12 months and 24 months)
- EQ-5D-3L questionnaire(1 month, 12 months and 24 months)
- Economic analysis objective(2 years)
- Primary sustained clinical improvement(1 month, 12 months and 24 months)