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:

  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 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 ]

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.


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