Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Condition: Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions; Moderate or Severe Claudication (Rutherford Category 2 or 3); Critical Limb Ischemia (Rutherford Category 4 or 5)
MeSH terms: Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Observational

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.
    

Detailed description: 
      • 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
    

Intervention name(s): Implantation of Eluvia stent
Intervention type(s): Device
Intervention description(s): Implantation of Eluvia stent
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Symptomatic peripheral artery disease with femoropopliteal lesions:

          -  Moderate or severe claudication (Rutherford category 2 or 3)

          -  Critical limb ischemia (Rutherford category 4 or 5) Age: ≥19 years, but not older than
             85 years
      
Keywords: Peripheral artery disease; femoropopliteal; drug-eluting stent; restenosis