Zilver PTX Drug-Eluting Peripheral Stent Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Longer Stents

Group Type EXPERIMENTAL

Longer Zilver PTX Stents

Intervention Type DEVICE

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

Shorter Stents

Group Type EXPERIMENTAL

Shorter Zilver PTX Stents

Intervention Type DEVICE

Treatment with Zilver PTX stents 80 mm or shorter only

Interventions

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Longer Zilver PTX Stents

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

Intervention Type DEVICE

Shorter Zilver PTX Stents

Treatment with Zilver PTX stents 80 mm or shorter only

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No