Zilver Flex Post-Market Study in Japan

NCT ID: NCT02254356

Last Updated: 2018-03-30

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

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-12-26

Brief Summary

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Japanese post market clinical study of the Zilver Flex device.

Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD)

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

Group Type EXPERIMENTAL

Zilver Flex Bare Metal Stent

Intervention Type DEVICE

Interventions

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Zilver Flex Bare Metal Stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Dake, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA

Locations

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Fukuoka Sanno Hospital

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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12-005-FLX

Identifier Type: -

Identifier Source: org_study_id

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