Zilver PTX Delivery System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

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Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Eluting Stent

Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent

Group Type EXPERIMENTAL

Zilver® PTX® Drug-Eluting Peripheral Stent

Intervention Type DEVICE

Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Interventions

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Zilver® PTX® Drug-Eluting Peripheral Stent

Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
* Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria

* Patient is \< 18 years of age
* Patient unable to complete required follow-up assessments
* Patient unwilling to sign and date the informed consent
* Simultaneous participation in another investigational drug or device study
* Pregnant, breastfeeding or planning to become pregnant in the next 5 years
* Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No