DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Occlusion of the below-knee artery 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 II. This part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. Totally 130 patients will be entered into this part. They should suffer ischemic symptom with Rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibial、posterior tibial or peroneal artery). According to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. They will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Obvious stenosis or occlusion in below-knee popliteal artery
- •No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
- •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 target 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 below-knee artery 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