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Updated: Feb 15, 2026

A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis

Published on: May 14, 2013

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Use of a novel embolic filter in carotid artery stenting: 30-Day results from the EMBOLDEN Clinical Study

William A Gray1, Manish Mehta2, Firas Alani3

  • 1Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|January 10, 2018
PubMed

Insights

The GORE Embolic Filter (GEF) demonstrated safety and effectiveness in carotid artery stenting for high-risk patients. This novel filter design achieved low rates of death, stroke, and myocardial infarction, exceeding performance goals.

Area of Science:

  • Cardiovascular Interventions
  • Medical Device Technology
  • Vascular Surgery

Background:

  • Carotid artery stenting (CAS) requires embolic protection to prevent complications.
  • Filter design balances trackability with capture efficiency.
  • The GORE Embolic Filter (GEF) utilizes a hybrid construction to optimize these parameters.

Purpose of the Study:

  • To evaluate the safety and efficacy of a novel embolic protection filter (GEF) during CAS.
  • To assess the GEF's performance in patients with severe carotid stenosis at high risk for carotid endarterectomy (CEA).

Main Methods:

  • The EMBOLDEN study enrolled 250 high-risk patients undergoing CAS with the GEF and an approved stent.
  • The primary outcome was a composite of death, stroke, and myocardial infarction (MI) at 30 days.
  • Outcomes were assessed by independent neurological and angiographic core labs.

Main Results:

  • Successful deployment of the GEF was achieved in 96.4% of procedures.
  • The primary endpoint (30-day death, stroke, MI) occurred in 4.0% of subjects, significantly below the performance goal (P < 0.001).
  • Thirty-day rates for death/major stroke and death/any stroke were 1.2% and 3.6%, respectively. Major adverse events were 5.4% in octogenarians versus 3.2% in non-octogenarians.

Conclusions:

  • The GEF demonstrated high deployment success rates in high-risk patients undergoing CAS.
  • The study met its primary endpoint, showing low rates of death, stroke, and MI, confirming the GEF's safety and effectiveness.
Abstract

Keywords:
carotid artery diseaseembolic protection devicesstent restenosisstroke

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