Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

• 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

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)