Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Clinical driven target lesion revascularization (TLR)
研究概览
简要总结
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
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 (Participant)
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
- •Critical limb ischemia. Rutherford class 4-6
- •Crural disease, long lesions, more than 2 cm.
- •Life expectancy > 1year
- •> 18 years
排除标准
- •Pregnancy
- •Patients disapproval
- •Allergy to drug or contrast
结局指标
主要结局
Clinical driven target lesion revascularization (TLR)
时间窗: 12 months
Porportion of patients that needs retreatment in in the monitored arterial segment
Primary patency of treated crural vessels
时间窗: 12 months
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
次要结局
未报告次要终点
研究者
Torbjorn Fransson
Consultant, Vascular Surgery
Skane University Hospital