NCT02698345Unknown不适用
Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary patency rate
研究概览
简要总结
- Prospective, multi-center, single-arm registry study
- A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled.
- All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure.
- Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 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 > 85 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)
结局指标
主要结局
Primary patency rate
时间窗: 12 months after the index procedure
absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
次要结局
- Target vessel revascularization rate(12 months)
研究者
研究点 (1)
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