KCT0002972已完成未知
Comparison of intravascular ultrasound–guided vs. angiography-guided angioplasty and dual-antiplatelet v. triple-antiplatelet therapy for outcomes of drug-coated balloon in the treatment of femoropopliteal Artery disease (IVUS-DCB)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
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 or older
- •2) Symptomatic peripheral artery disease:
- •- Moderate or severe claudication (Rutherford category 2 or 3)
- •- Critical limb ischemia (Rutherford category 4 or 5)
- •3) Femoropopliteal artery disease (stenosis > 50%)
- •4) ABI <0.9
- •5) Patients with signed informed consent
排除标准
- •1) Acute critical limb ischemia
- •2) Severe critical limb ischemia (Rutherford category 6)
- •3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- •4) Patients requiring oral anticoagulation using warfarin or NOAC
- •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
- •11) Previous bypass surgery or stenting in the target femoropopliteal artery
- •12) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
研究者
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