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Introduction

Carotid Artery Disease is the buildup of fat and cholesterol deposits within the carotid arteries. The carotid arteries are located on both sides of the neck and supply blood to the brain. This plaque buildup, also called atherosclerosis, reduces blood flow to the brain and can ultimately lead to a stroke. Many people do not have symptoms of Carotid Artery Disease, but there are warning signs of an impending stroke. Some warning signs may include blurred or loss of vision, weakness and/or numbness of arm, leg or face on one side of the body, headache, slurred speech and loss of coordination. Treatment options to improve blood flow in the carotid arteries include lifestyle changes, medications, surgery and less-invasive procedures, such as placing a stent similar to the one used in this study, in the narrowed artery.

The purpose of this study is to confirm the PROTÉGÉ® GPS and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX® Embolic Protection Device are safe and effective in the treatment of carotid artery stenosis for subjects with a high risk for complications during carotid endarterectomy.

Design

  • Post approval study
  • Prospective, multi-center, non-randomized
    • 1500 subjects
    • Up to 100 clinical sites in the US

Primary Endpoints

  • Composite rate of death, ipsilateral CVA, procedure-related contralateral CVA, or myocardial infarction (MI) within 30 days post-procedure; and the rate of ipsilateral CVA from 31 days to one year.

Inclusion/Exclusion Criteria

  • Inclusion Criteria:
    • 18 years and above
    • Informed consent
    • Intent to use the PROTÉGÉ GPS and PROTÉGÉ RX and SpiderFX to treat carotid artery disease per Instructions for Use
    • Meet protocol-defined anatomical or clinical high risk criteria
    • Target lesion stenosis = 80% for asymptomatic subjects or = 50% stenosis for symptomatic subjects
  • Exclusion Criteria:
    • Subjects must not meet general or angiographic exclusion criteria as defined in the protocol
    • Subjects with contraindications as outlined in the Instructions for Use

Follow-up Schedule

First 500 subjects: Pre-discharge, 1 month, 6 months and 1 year post procedure
Next 1000 subjects: Pre-discharge and 1 month

Principal Investigators

Gary Ansel, MD, MidWest Cardiology Research Foundation, Columbus, OH
Robert Safian, MD, William Beaumont Hospitals, Detroit, MI

For additional information on this study email: Clinical@ev3.net or
Visit: clinicaltrials.gov: Identifier NCT00530504