Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Medtronic Endovascular2 sites in 1 country1,500 target enrollmentMay 2007

ConditionsCarotid Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Disease
Sponsor: Medtronic Endovascular
Enrollment: 1500
Locations: 2
Primary Endpoint: Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purposes of this study are:

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.
To evaluate rare and unanticipated adverse events.
To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

January 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•Subjects with contraindications as outlined in the Instructions for Use

Outcomes

Primary Outcomes

Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.

Time Frame: 30 Days

Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.