Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study

Study Overview
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Brief Summary
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Prospective, randomized, controlled, multi-center study A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria. Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions Patients will be followed clinically for 1 year after the procedure. Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Conditions
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Femoropopliteal Artery Disease

Intervention / Treatment
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* Device: Long stenting using drug-eluting stent (Zilver PTX)
* Device: Spot stenting using drug-eluting stent (Zilver PTX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical 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 or 5) Patients with signed informed consent Anatomical criteria: Target lesion length ≥150 mm by angiographic estimation Stenosis of more than 50% in femoropopliteal artery At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel. Exclusion Criteria: A. Clinical criteria Acute critical limb ischemia Severe critical limb ischemia (Rutherford category 6) Major bleeding history within prior 2 months Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents Age > 85 years Severe hepatic dysfunction (> 3 times normal reference values) Significant renal dysfunction (Serum creatinine > 2.0 mg/dl Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis LVEF(left ventricular ejection fraction) <40% or clinically overt congestive heart failure Pregnant women or women with potential childbearing Life expectancy <1 year due to comorbidity Angiographic criteria Previous bypass surgery or stenting of the superficial femoral artery Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion Popliteal artery stenosis >50% at P2 or P3 segment

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long stenting group<br> | Device: Long stenting using drug-eluting stent (Zilver PTX)<br>* Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty<br>|
| Active Comparator: Short stenting group<br> | Device: Spot stenting using drug-eluting stent (Zilver PTX)<br>* Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel revascularization rate | 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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Femoropopliteal Artery, Drug-eluting Stent, Endovascular Therapy