The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Occlusion of the stent or artificial blood vessel bypass
研究概览
简要总结
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.
详细描述
This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（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.
Trial participants will be randomized to either stent group or artificial blood vessel bypass group.
Patients 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.
This study will be conducted at 3 centers in Beijing, China.
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
- 45 Years 至 80 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 ≥45 year-old and ≤80 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 total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
- •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.
- •No available saphenous vein.
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 artificial blood vessel 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)
- Rate of amputation(36 months)
- Increase in Ankle Brachial Index(36 months)
- Restenosis measured by Duplex Ultrasound or CTA(36 months)