NCT02701881Unknown4 期
Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Primary patency rate
研究概览
简要总结
- Prospective, randomized, controlled, multi-center study
- A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria.
- Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions
- Patients will be followed clinically for 1 year after the procedure.
- Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria:
- •Age 19 years of older
- •Symptomatic peripheral artery disease:
- •Moderate or severe claudication (Rutherford category 2 or 3)
- •Critical limb ischemia (Rutherford category 4 or 5)
- •Patients with signed informed consent
- •Anatomical criteria:
- •Target lesion length ≥150 mm by angiographic estimation
- •Stenosis of more than 50% in femoropopliteal artery
- •At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
排除标准
- •A. Clinical criteria
- •Acute critical limb ischemia
- •Severe critical limb ischemia (Rutherford category 6)
- •Major bleeding history within prior 2 months
- •Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
- •Age > 85 years
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant renal dysfunction (Serum creatinine > 2.0 mg/dl
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •LVEF(left ventricular ejection fraction) <40% or clinically overt congestive heart failure
- •Pregnant women or women with potential childbearing
- •Life expectancy <1 year due to comorbidity
- •Angiographic criteria
- •Previous bypass surgery or stenting of the superficial femoral artery
- •Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion
- •Popliteal artery stenosis >50% at P2 or P3 segment
研究组 & 干预措施
Long stenting group
Experimental
干预措施: Long stenting using drug-eluting stent (Zilver PTX) (Device)
Short stenting group
Active Comparator
干预措施: Spot stenting using drug-eluting stent (Zilver PTX) (Device)
结局指标
主要结局
Primary patency rate
时间窗: 12 months
Absence of restenosis \>50%
次要结局
- Target vessel revascularization rate(12 months)
研究者
研究点 (2)
Loading locations...
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