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Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

NCT00530504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2019-03-05

Study results available
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Summary

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.

Conditions

  • Carotid Artery Disease

Interventions

DEVICE

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

Carotid artery stenting with distal embolic protection.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Gary Ansel, MD · MidWest Cardiology Research Foundation

  • Robert Safian, MD · William Beaumont Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530504 on ClinicalTrials.gov