korean multicenter registry of eluvia stent for femoropopliteal artery disease (k-eluvia registry)

Conditions: Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions; Moderate or Severe Claudication (Rutherford Category 2 or 3); Critical Limb Ischemia (Rutherford Category 4 or 5)

Summary: * prospective, multi-center single-arm observational study * a total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. * patients will be followed clinically for 12 months after the procedure. * an imaging study (duplex ultrasound, ct or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months. * ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.

enrollment (day 0): 1) written consent post pta (day 1 \~3): 1. symptom: rutherford class 2. adverse event 3. ankle-brachial index 4. laboratory test: - egfr, cr, alt, ast * hb, wbc, platelet 5. concomitant medication regular follow-up visits visit 1 (post-pta 30±14 days): 1. symptom: rutherford class 2. physical examination 3. concomitant medication 4. adverse event 5. laboratory test: * ac glucose, egfr, cr, alt, ast * hb, wbc, platelet * lipid level (total cholesterol, ldl-c, triglyceride, hdl-c) * hba1c in case of dm * hscrp visit 2 (post-pta 6 months ± 30 days): 1. symptoms: rutherford class 2. physical examination 3. ankle-brachial index 4. concomitant medication 5. adverse event visit 3 (post-pta 12 months ± 30 days): (mandatory) 1. symptoms: rutherford class 2. physical examination 3. ankle-brachial index 4. duplex ultrasound, ct, or catheter angiography 5. concomitant medication 6. adverse event 7) biplane radiograph of femur for evaluation of stent fracture 8) laboratory test: - ac glucose, egfr, cr, alt, ast * hb, wbc, platelet * lipid level (total cholesterol, ldl-c,triglyceride, hdl-c) * hba1c in case of dm * hscrp

Eligibility criteria:
inclusion criteria: * age 19 years of older * symptomatic peripheral artery disease: moderate or severe claudication (rutherford category 2 or 3) and critical limb ischemia (rutherford category 4-5) * femoropopliteal artery lesions with stenosis \> 50% * abi \< 0.9 before treatment * patents treated with eluvia stent for femoropopliteal artery disease * patients with signed informed consent exclusion criteria: * acute critical limb ischemia * severe critical limb ischemia (rutherford category 6) * known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents * in-stent restenosis lesions (restenosis lesions without previously implanted stents are eligible to the enrollment) * bypass graft lesions * age \> 85 years * severe hepatic dysfunction (\> 3 times normal reference values) * 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 * untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Keywords: peripheral artery disease femoropopliteal drug-eluting stent restenosis