Combination therapy of Atherectomy plus drug-coated balloon versus drug-coated balloon for complex femoropopliteal artery disease

Yonsei University Health System, Severance Hospital0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
•4) Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
•5) Patients with signed informed consent

•1) Acute critical limb ischemia
•2) Severe critical limb ischemia (Rutherford category 6)
•3) Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
•4) Age > 85 years
•5) Severe hepatic dysfunction (> 3 times normal reference values)
•6) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
•7) LVEF < 35% or clinically overt congestive heart failure
•8) Pregnant women or women with potential childbearing
•9) Life expectancy <1 year due to comorbidity
•10) Previous bypass surgery or stenting in the target femoropopliteal artery
•11) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

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