Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- limb salvage
研究概览
简要总结
Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.
详细描述
The aim of this study was to estimate validity of distal venous arterialisation (DVA) as a limb salvage procedure. This prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (CLI) treated during 2009 year at Clinic for vascular surgery, Clinical Center of Serbia in Belgrade. Patients were divided in two groups, 10 treated with DVA and 20 conservatively (CT) using antiplatelet drugs.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries
- •Sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning
- •localized infective of necrotic process up to the metatarsal level
- •Satisfactory general patient condition
排除标准
- •advanced lower limb ischemia
- •venous insufficiency of lower limb
研究组 & 干预措施
critical ischemia
干预措施: distal venous arterialisation (Procedure)
Control
Best medical treatment
干预措施: Aspirin (Drug)
结局指标
主要结局
limb salvage
时间窗: 1 year
The investigators will estimate clinical improvement in patients with critical limb ischemia underwent of distal venous arterialisation. Comparative group consist patients treated with antiplatelet drugs.
次要结局
- lactate level in the blood of deep venous system(1 year)