Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA 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 femoropopliteal 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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Femoropopliteal Artery Disease

Intervention / Treatment
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* Device: innova 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 4-5) Femoropopliteal 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 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 |
| --- | --- |
| K-INNOVA<br>Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific). | Device: innova 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 rate | Absence of restenosis >50% | 12 months after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization rate |  | 12 months | 
| Stent fracture rate |  | 12 months | 
| Quality of life | 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, Femoropopliteal Artery, Nitinol Stent, Restenosis