Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)

Study Overview
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Brief Summary
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Prospective, single-arm, multi-center registry study A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included. Patients will be followed clinically for 12 months after the procedure. Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months. Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)

Conditions
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Iliac Artery Disease

Intervention / Treatment
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* Device: Epic stent (Boston Scientific)


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) Critical limb ischemia (Rutherford category 4) Iliac artery lesions with stenosis > 50% ABI <0.9 Patients with signed informed consent Exclusion Criteria: Acute critical limb ischemia Severe critical limb ischemia (Rutherford category 5 or 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 aorta or 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 |
| --- | --- |
| K-EPIC<br>Patients with femoropopliteal artery disease undergoing endovascular therapy using Epic stent (Boston Scientific). | Device: Epic stent (Boston Scientific)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization rate |  | 12 months | 
| Stent fracture rate |  | 12 months | 
| Quality of life by standardized questionnaires |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, Iliac artery, nitinol stent, restenosis