NCT02563535已完成4 期
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Late Lumen Loss (LLL) in the target lesion documented by angiography
研究概览
简要总结
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.
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
- •age>18 years
- •critical limb ischemia (Rutherford class 4-6)
- •angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled
排除标准
- •need for major amputation known before intervention
- •allergy to Paclitaxel
- •contraindication for combined antiplatelet treatment
- •life expectancy <1 year
- •hypersensitivity or contraindication to one of the study drugs
- •lack of consent
研究组 & 干预措施
Drug-eluting balloon
Experimental
angioplasty with Litos drug-eluting balloon
干预措施: DEB (Device)
conventional PTA
Active Comparator
angioplasty with conventional balloon
干预措施: PTA (Device)
结局指标
主要结局
Late Lumen Loss (LLL) in the target lesion documented by angiography
时间窗: 6 months
Late Lumen Loss (LLL) in the target lesion documented by angiography
次要结局
- Number of events of angiographic occlusive restenosis(6 months)
- Number of events of target lesion revascularization (TLR)(12 months)
研究者
Leonardo Bolognese, MD
MD
Ospedale San Donato
研究点 (1)
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