At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 enrolled
Drug / intervention
GORE Flow Reversal System (GFRS)device
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.
The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy
In Brief
A Phase 3 clinical trial evaluating GORE Flow Reversal System (GFRS) for Carotid Artery Stenosis. Completed, enrolled 245 participants across 2 sites.
Detailed Summary
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Stenosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedJan 2008
Primary CompletionSep 2008
TodayJul 2026
First PostedJan 15, 2008
Enrollment StartJul 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.5 years ago
Interventions
GORE Flow Reversal System (GFRS)device
Carotid artery angioplasty and stenting with embolic protection