ACCULINK for Revascularization of Carotids in High Risk Patients "The ARCHeR Trial"

Completed

Phase 2/3 Results

Summary of Purpose

1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA) 2. To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA). 3. To demonstrate equivalence in the safety and performance of...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 10 September 2008.

1 May 2000 13 Sep 2005 1 Oct 2003 1 Nov 2003 1 Sep 2008 Unavailable
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

Contacts

  • William Gray, M.D. Columbia University Medical Center, New York, NY 10032, USA. wg2131@columbia.edu

    lnh1@acsu.buffalo.edu