Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Occlusion of the stent or bypass
研究概览
简要总结
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.
详细描述
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients volunteer to join the trial and sign the formal consent.
- •The patients are ≥55 year-old and ≤75 year-old.
- •The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or
- •The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
- •The lesion of the femoral artery should be TASC B、C or D.
- •The femoral-popliteal artery has never received bypass or endovascular therapy before.
- •No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
- •No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
- •No surgical contraindications;no infection in operation region.
- •Be diagnosed with DM for at least 1 year.
排除标准
- •Refuse random treatment.
- •Previous operations on the superficial femoral artery.
- •Acute lower extremity arterial thrombosis.
- •Serious major organ failure.
- •Allergic to the contrast agent or has contrast nephropathy.
- •No clinical compliance or unfit to join the trial
结局指标
主要结局
Occlusion of the stent or bypass
时间窗: 36 months
次要结局
- Mortality(30 days)
- Rate of limb salvage(36 months)
- Procedural complications, defined as any adverse event(36 months)
- Quality of Life assessment(36 months)
- Restenosis measured by Duplex Ultrasound or CTA(36 months)
研究者
Liu Chang-wei
Vascular Surgery
Peking Union Medical College Hospital