Zilver® PTX® in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-02-09

Brief Summary

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The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

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Detailed Description

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Conditions

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Peripheral Artery 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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Zilver® PTX® VI

Group Type EXPERIMENTAL

Zilver® PTX® Drug-Eluting Peripheral Stent

Intervention Type DEVICE

Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Interventions

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Zilver® PTX® Drug-Eluting Peripheral Stent

Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
* Stenotic (\>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
* Reference vessel diameter of 4-9 mm
* Lesion length up to 140 mm

Exclusion Criteria

* Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
* Previous stent in the study vessel
* Bypass graft with an anastomosis in the study vessel
* Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
* No patent vessel of runoff

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No