Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Not Applicable

Completed

• Conditions: Carotid Artery Disease
• Interventions: Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device

• Registration Number: NCT00530504
• Lead Sponsor: Medtronic Endovascular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-17
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-07-28
• Results First Submitted QC: 2015-08-14
• Results First Posted: 2015-09-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Wellmont Medical Center; 🇺🇸 Kingsport, Tennessee, United States

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States