Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

Completed

Phase 4 Results

Summary of Purpose

To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 16 October 2008.

1 Nov 2005 1 Feb 2006 1 Dec 2007 1 Jan 2008 1 Oct 2008 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

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

Contacts

Not available