KCT0002981已完成未知
Comparison of the PrimAry Long versus Short Coverage with Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-intiated Multicenter Randomized Phase 4 Clinical Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 112
研究概览
简要总结
There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6±67.2 vs. 131.3±48.7mm, p<0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, p = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, p = 0.044).
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Age 19 years of older
- •2) Symptomatic peripheral artery disease:
- •- Moderate or severe claudication (Rutherford category 2 or 3)
- •- Critical limb ischemia (Rutherford category 4 or 5)
- •3) Patients with signed informed consent
- •B. Anatomical criteria:
- •1) Target lesion length =150 mm by angiographic estimation
- •2) Stenosis of more than 50% in femoropopliteal artery
- •3) At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
排除标准
- •1) Acute critical limb ischemia
- •2) Severe critical limb ischemia (Rutherford category 6)
- •3) Major bleeding history within prior 2 months
- •4) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
- •5) Age > 85 years
- •6) Severe hepatic dysfunction (> 3 times normal reference values)
- •7) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •8) LVEF <40% or clinically overt congestive heart failure
- •9) Pregnant women or women with potential childbearing
- •10) Life expectancy <1 year due to comorbidity
- •B. Angiographic criteria
- •1) Previous bypass surgery or stenting of the superficial femoral artery
- •2) Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%
- •stenosis or occlusion)
- •3) Diseased distal popliteal artery (P2 or P3 segment) with stenosis > 50%
研究者
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