Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study "CREATE PAS"


Phase 4 Results

Summary of Purpose

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...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 24 September 2015.

1 May 2007 14 Sep 2007 1 Jan 2014 1 Jan 2014 1 Aug 2015 28 Jul 2015
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment