Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I) "ACT I"


Phase 3 Results

Summary of Purpose

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease. Trial Stopped: Business decision and not a result of any patient or product safety issues.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 13 October 2014.

1 Apr 2005 1 Apr 2005 1 Mar 2013 1 Mar 2013 1 Oct 2014 2 Apr 2014
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment