NCT00715416已完成4 期
Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
Vienna General Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2004年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
研究概览
简要总结
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
- •critical limb ischemia in patients with stenosis or occlusions originating in the SFA
- •up to 25 cm length of stenosis/occlusion
排除标准
- •previous bypass surgery at the site of treatment
- •history of intolerance of anti-platelet therapy
- •adverse reaction to heparin
- •bleeding diathesis
- •creatinine >2.5 mg/dL
- •active bacterial infection
- •allergy to contrast media
- •previous stent placement at or immediately adjacent to the target lesion
结局指标
主要结局
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
时间窗: 3, 6, 12 months
次要结局
- ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure(3, 6, 12 months)
研究者
研究点 (2)
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