CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
GORE® Embolic Filterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00766493
NCT00766493Phase 3Completed
CompareCT.gov

GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)

W.L.Gore & Associates·interventional·Posted Oct 6, 2008·Updated Sep 29, 2016

In Brief

A Phase 3 clinical trial evaluating GORE® Embolic Filter for Carotid Artery Stenosis. Completed, enrolled 250 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Stenosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartJan 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago

Interventions

GORE® Embolic Filterdevice

Embolic protection during carotid stenting