Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

Study Overview
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Brief Summary
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This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Official Title
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Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

Conditions
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Peripheral Arterial Disease (PAD)

Intervention / Treatment
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* Device: Zilver® Paclitaxel-Eluting Peripheral Stent
* Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
* Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis Symptoms of peripheral arterial disease (Rutherford 2-4) Exclusion Criteria: Pregnant, breastfeeding, or planning to become pregnant in the next 5 years Less than 18 years old Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis Previous stent in the study vessel

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent 1<br>Zilver® PTX Stent | Device: Zilver® Paclitaxel-Eluting Peripheral Stent<br>* Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.<br>|
| Experimental: Stent 2<br>Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating | Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating<br>* Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.<br>|
| Experimental: Stent 3<br>Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating | Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating<br>* Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent diameter stenosis within the study lesion evaluated by conventional angiography. | Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters. | 6 months |