Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年3月4日

试验速览

暂无简介。

•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) Atherosclerotic popliteal artery disease, stenosis > 50% Treated with InPACT DEB balloon
•4) Patients with signed informed consent

•1) Acute critical limb ischemia
•2) Severe critical limb ischemia (Rutherford category 6)
•3) Involvement of SFA disease with stenosis
•4) Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
•5) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
•6) Age > 85 years
•7) Severe hepatic dysfunction (> 3 times normal reference values)
•8) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
•9) LVEF < 40% or clinically overt congestive heart failure
•10) Pregnant women or women with potential childbearing
•11) Life expectancy <1 year due to comorbidity
•12) Previous bypass surgery or stenting for the target popliteal artery
•13) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

发起方