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Gore Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (Gore Embolden) Protocol GEF-06-08

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Trial Conditions
  • Carotid Artery Disease
  • Carotid Disease
What is the purpose of this trial?

To compare the 30 day safety and efficacy of the Gore Embolic Filter used in conjunction with FDA approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.

Date & Status

Recruiting

Eligibility

Subject must be at High Risk for Carotid Endarterectomy for Enrollment

 

Subject must be 18 yrs. or older
 
Subject is willing to provide written informed consent prior to Enrollment
 
Male, infertile female, or non-lactating female
 
Subject is either Symptomatic: amaurosis fugax in the hemisphere supplied by the target
vessel, TIA or non-disabling stroke within 6 months, with carotid stenosis 50% or greater OR is Asymptomatic: with carotid stenosis 80% or greater
Facilities
  • St. Elizabeth's Medical Center - Recruiting
For more information about this trial, contact

Melissa Antonellis
Melissa.Antonellis@steward.org
Phone: 617-562-7825


Other Information

Sponsor: W.L. Gore & Associates
Trial ID: Carotid Disease
Volunteers:  Not Accepting Healthy Volunteers

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