At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,397 enrolled
Drug / intervention
Gore Flow Reversal System +1 moredevice
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 Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
In Brief
A clinical study evaluating Gore Flow Reversal System and Gore Embolic Filter for Carotid Stenosis and 10 related conditions. Completed, enrolled 1,397 participants across 39 sites.
Detailed Summary
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionNov 2013
Study CompletionJan 2014
TodayJul 2026
First PostedApr 28, 2011
Enrollment StartApr 1, 2011
Primary CompletionNov 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.2 years ago
Interventions
Gore Flow Reversal Systemdevice
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Gore Embolic Filterdevice
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting