Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 主要终点
- course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
研究概览
简要总结
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
详细描述
Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment.
With the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation.
The promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or 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
- 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
- •Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length
排除标准
- •Previous bypass surgery at the site of treatment,
- •Previous stent placement at or immediatly adjacent to target lesion,
- •History of anti-platelet-therapy intolerance or adverse reaction to heparin,
- •Bleeding diathesis,
- •Creatinine > 2,5 mg/dL,
- •Active bacterial infection,
- •Allergy to contrast media
结局指标
主要结局
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
次要结局
- occurence of restenosis within 6 months after endovascular treatment