NCT01285986已完成不适用
Scandinavian Miller Collar Study
University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 352 人开始时间: 1995年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Primary graft patency
研究概览
简要总结
Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical limb ischemia
- •Need for bypass surgery
排除标准
- •Can not participate in follow-up
- •Has suitable saphenous vein
结局指标
主要结局
Primary graft patency
时间窗: Up to five years
Follow-up at 1, 3, 6, and 12. Thereafter at most 5 years or until death of patient or amputation of limb. Primary graft patency = patent graft without any intervention to open up or prevent a graft ocklusion. Methods used for verification of patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.
次要结局
- Secondary Patency(Up to five years)
研究者
研究点 (2)
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