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

Study Overview
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Brief Summary
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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.

Detailed Description
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Enrollment (day 0): 1) Written consent Post PTA (Day 1  3): Symptom: Rutherford class Adverse event Ankle-brachial index Laboratory test: - eGFR, Cr, ALT, AST Hb, WBC, platelet Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days): Symptom: Rutherford class Physical examination Concomitant medication Adverse event 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): Symptoms: Rutherford class Physical examination Ankle-brachial index Concomitant medication Adverse event Visit 3 (post-PTA 12 months ± 30 days): (Mandatory) Symptoms: Rutherford class Physical examination Ankle-brachial index Duplex ultrasound, CT, or catheter angiography Concomitant medication 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

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

Conditions
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Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)

Intervention / Treatment
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* Device: Implantation of Eluvia stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 years of older Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and 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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eluvia<br>Patients treated with Eluvia stent | Device: Implantation of Eluvia stent<br>* Implantation of Eluvia stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Absence of stenosis >50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 12 months | 
| Ruthford category | Rutherford category - symptom status by Rutherford category | at 12 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 | at 12 months | 
| stent fracture rate | stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, femoropopliteal, drug-eluting stent, restenosis