Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

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

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2014-01-31

Brief Summary

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The purposes of this study are:

1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.
2. To evaluate rare and unanticipated adverse events.
3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

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Detailed Description

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Conditions

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Carotid 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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Device

Group Type EXPERIMENTAL

PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device

Intervention Type DEVICE

Carotid artery stenting with distal embolic protection.

Interventions

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PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device

Carotid artery stenting with distal embolic protection.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years and above
* Informed consent
* Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
* Meet Instruction for Use (IFU)/ Centers for Medicare \& Medicaid Services (CMS)defined anatomical or clinical high risk criteria