Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

• Prospective, multi-center single-arm observational study

Screening (day 0):

• Medical history and demography of the patient reviewed
• Inclusion/exclusion eligibility will be checked
• Physical examination (Height, weight)
• Laboratory test

• BUN, eGFR, Cr.
• Hb, WBC, platelet
• Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
• Ankle-brachial index
• Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
• Medication

Enrollment (day 0):

• Written consent

Post PTA (Day 1 ~3):

• Adverse event
• Ankle-brachial index
• Laboratory test:

• BUN, eGFR, Cr.
• Hb, WBC, platelet
• Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days)

• 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)

• Symptoms: Rutherford class
• Ankle-brachial index
• Concomitant medication
• Adverse event Visit 3 (post-PTA 12 months ± 60 days)

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• Symptoms: Rutherford class
• Ankle-brachial index
• Duplex ultrasound, CT, or catheter angiography
• Biplane radiograph of femur for evaluation of stent fracture
• 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)

• Symptom: Rutherford category
• Adverse events

Inclusion criteria

• Age 19 years of older
• Symptomatic peripheral artery disease:

• Moderate or severe claudication (Rutherford category 2 or 3)
• 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)