The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Salvage limb rate (for CLI patients)
研究概览
简要总结
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Symptomatic peripheral artery disease:
- •Moderate or severe claudication (Rutherford category 2 or 3)
- •Critical limb ischemia (Rutherford category 4 or 5)
- •Atherosclerotic popliteal artery disease (stenosis > 50%)
- •Patients with signed informed consent
排除标准
- •Acute critical limb ischemia
- •Severe critical limb ischemia (Rutherford category 6)
- •Involvement of SFA disease with stenosis
- •Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
- •Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
- •Age > 80 years
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •LVEF < 40% or clinically overt congestive heart failure
- •Pregnant women or women with potential childbearing
- •Life expectancy <1 year due to comorbidity
- •Previous bypass surgery or stenting for the target popliteal artery
- •Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
研究组 & 干预措施
stent deployment
metal bare stent intervention
干预措施: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) (Device)
drug-coating balloon
drug-coating balloon (Orchid) intervention
干预措施: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) (Device)
结局指标
主要结局
Salvage limb rate (for CLI patients)
时间窗: 12 months after the index procedure
Limb Salvage is defined as the freedom from secondary major amputation
Primary patency of claudicant patients
时间窗: 12 months after the index procedure
Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
次要结局
- Major Adverse Events at 12-month Post Procedure(12 months)
- TcpO2(12 months)
- Wagnar classification(12 months)
- ABI(12 months)
- Rutherford classification(12 months)
- Index Limb Ischemia at 12-month Follow up(12 months)
- Target vessel revascularization rate(12 months)
研究者
Yong-Quan Gu
Director, vascular suregry department
Xuanwu Hospital, Beijing