NCT01359423已完成不适用
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- The rate of binary restenosis
研究概览
简要总结
Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.
Study design :
- Prospective, randomized, multi-center study
- A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.
- Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.
- Patients will be followed clinically for 1 year after the procedure.
- Angiographic or CT follow-up 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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria:
- •Age 20 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 ≥80 mm by angiographic estimation
- •Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
- •At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
排除标准
- •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 < 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 occlusion)
研究组 & 干预措施
long coverage
Experimental
Primary long full coverage stenting
干预措施: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long (Drug)
short spot
Active Comparator
primary short spot stenting
干预措施: short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome. (Drug)
结局指标
主要结局
The rate of binary restenosis
时间窗: 12months after the index procedure
The rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) in the treated segment 12 months after intervention, as determined by computed tomographic angiography (CTA) or catheter angiography according to the stenting strategy
次要结局
- Ankle-brachial index, etc(at 12 months according to the stenting strategy)
研究者
研究点 (1)
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