Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Yonsei University100 enrolled

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 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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Clinical patency

Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or \> 50% restenosis on imaging studies at 24 months.

Time frame: at 24 months

Secondary Outcomes

Ankle-brachial index

Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm

Time frame: at 12 and 24 months

Ruthford category

Rutherford category - symptom status by Rutherford category

Time frame: at 12 and 24 months

target lesion revascularization

Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (\>50% stenosis) in the target lesion

Time frame: at 12 and 24 months

stent fracture rate

stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections

Time frame: at 12 and 24 months

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes