Clinical Trial: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
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.
Detailed Summary:
Sponsor: Medtronic Endovascular
Current Primary Outcome: Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. [ Time Frame: 30 Days ]
Original Primary Outcome:
- Composite of death, ipsilateral cerebrovascular accident (CVA), procedure-related CVA,or MI at 30 days post-procedure.
- Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure; and the rate of ipsilateral stroke from 31 days to one year.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic Endovascular
Dates:
Date Received: September 14, 2007
Date Started: May 2007
Date Completion:
Last Updated: September 24, 2015
Last Verified: August 2015