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

Cook Group Incorporated176 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

176

Conditions

Peripheral Arterial Disease (PAD)

Interventions

Zilver® Paclitaxel-Eluting Peripheral StentDEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coatingDEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coatingDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Klinikum Hochsauerland

Arnsberg, Germany

Universitäts Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Krankenhaud Bucholz

Buchholz, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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