NCT01343667CompletedNot Applicable
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
W.L.Gore & Associates77 sites in 1 country1,397 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,397
- Locations
- 77
- Primary Endpoint
- Major Adverse Events (MAE)
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Major Adverse Events (MAE)
Time Frame: Onset from start of index procedure to 30-day follow-up assessment
Major Adverse Events include death, stroke and myocardial infarction
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (77)
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