Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)

Overview

* 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

Conditions