korean multicenter registry of eluvia stent for femoropopliteal artery disease

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 24 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.

• prospective, multi-center single-arm observational study screening (day 0): 1. medical history and demography of the patient reviewed 2. inclusion/exclusion eligibility will be checked 3. physical examination (height, weight) 4. laboratory test * bun, egfr, cr. * hb, wbc, platelet * lipid level (total cholesterol, ldl-c, triglyceride, hdl-c) 5. ankle-brachial index 6. imaging study (ct/mr angiography, doppler ultrasound, or catheter angiography) 7. medication enrollment (day 0): 1) written consent post pta (day 1 \~3): 1. adverse event 2. ankle-brachial index 3. laboratory test: * bun, egfr, cr. * hb, wbc, platelet 4. concomitant medication regular follow-up visits visit 1 (post-pta 30±14 days) 1) symptom: rutherford class 2) laboratory test: * bun, egfr, cr. * hb, wbc, platelet 3) concomitant medication 4) adverse event visit 2 (post-pta 6 months ± 30 days) 1. symptoms: rutherford class 2. ankle-brachial index 3. concomitant medication 4. adverse event visit 3 (post-pta 12 months ± 60 days) 1. symptoms: rutherford class 2. ankle-brachial index 3. duplex ultrasound, ct, or catheter angiography 4. biplane radiograph of femur for evaluation of stent fracture 5. laboratory test * bun, egfr, cr. * hb, wbc, platelet * lipid level (total cholesterol, ldl-c, triglyceride, hdl-c) 6)concomitant medication 7) adverse event visit4 (post-pta 24 months ± 60 days) 1. symptom: rutherford category 2. adverse events

Eligibility criteria:
inclusion criteria: 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 4-5) 3. femoropopliteal artery lesions with stenosis \> 50% 4. abi \< 0.9 before treatment 5. patents treated with eluvia stent for femoropopliteal artery disease 6. patients with signed informed consent exclusion criteria: 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. in-stent restenosis lesions (restenosis lesions without previously implanted stents are eligible to the enrollment) 5. bypass graft lesions 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. untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Keywords: peripheral artery disease femoropopliteal drug-eluting stent restenosis