Zilver PTX Drug-Eluting Peripheral Stent Study

Cook Group Incorporated45 enrolled

Overview

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Longer Zilver PTX StentsDEVICE

Treatment with at least one 100 mm or longer Zilver PTX stent

Shorter Zilver PTX StentsDEVICE

Treatment with Zilver PTX stents 80 mm or shorter only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * One de novo or restenosed artherosclerotic lesion with \> 50% diameter stenosis * Reference vessel diameter of 4 - 9 mm * Rutherford category ≥ 2 * Resting ankle brachial index \< 0.9 Exclusion Criteria: * Prior stent in the study vessel * Significant stenosis (\> 50%) or occlusion of inflow tract not successfully treated before the study procedure * Lacks at least one patent runoff vessel * Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Locations (4)

Herz-Zentrum

Bad Krozingen, Germany

Evangelische Krankenhaus Königin Elisabeth Herzberge

Berlin, Germany

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, Germany

INSELSPITAL, Universitätsspital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

Percent Change in Stent Length Upon Deployment

Time frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)

Data from ClinicalTrials.gov

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