NCT00459888已完成4 期
CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Clinical patency
研究概览
简要总结
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the "Instructions For Use" of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only data are collected that have been made available conform the Standard the Standards of Care for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.
- •Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.
排除标准
- 未提供
结局指标
主要结局
Clinical patency
时间窗: 12 months
次要结局
- Technical success(procedure)
- angiographic outcomes for the subgroup of patients in which made available.(12 months)
- Primary patency rate(12 months)
- Limb-salvage rate(12 months)
- Serious adverse events(12 months)
- Clinical success (improvement of Rutherford classification)(12 months)
- Health Economics assessment(12 months)
研究者
研究点 (8)
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