Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)

Study Overview
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Brief Summary
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Prospective, multi-center, single-arm registry study A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled. All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure. Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.

Conditions
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Popliteal Artery Disease

Intervention / Treatment
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* Device: drug-eluting balloon (In.PACT Admiral, Medtronic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 years or older Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) Critical limb ischemia (Rutherford category 4 or 5) Atherosclerotic popliteal artery disease (stenosis > 50%) Patients with signed informed consent Exclusion Criteria: Acute critical limb ischemia Severe critical limb ischemia (Rutherford category 6) Involvement of SFA disease with stenosis Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk). Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent 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 Previous bypass surgery or stenting for the target popliteal artery Untreated inflow disease of the ipsilateral pelvic or femoropopliteal 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-POP<br>Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic) | Device: drug-eluting balloon (In.PACT Admiral, Medtronic)<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% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months | 12 months after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel revascularization rate | frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Popliteal artery disease, drug-eluting balloon, angioplasty