GORE Flow Reversal System and GORE Embolic Filter Extension Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Neurology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | January 2014 |
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
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.
associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for
embolic protection during carotid artery stenting.
Physicians will have the opportunity to select which embolic protection device, the GORE
Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting
procedure.
This study is not designed to compare study endpoints between the two treatment arms.
Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting
procedure.
This study is not designed to compare study endpoints between the two treatment arms.
Inclusion Criteria:
- Patient, or patient's legal representative, is able and willing to provide informed
consent.
- Patient must be at least 18 years of age or older.
- Patient will be selected and treated according to the GORE Flow Reversal System
Instructions for Use (IFU) or the GORE Embolic Filter IFU.
Exclusion Criteria:
- Patient is contraindicated for the embolic protection device arm they are selected by
the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE
Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE
Embolic Filter is selected
If the patient is contraindicated for both arms (devices) they may not be enrolled.
We found this trial at
39
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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