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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01343667 |
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Date of registration:
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25/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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GORE Flow Reversal System and GORE Embolic Filter Extension Study
FREEDOM |
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Scientific title:
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The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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1397 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01343667 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Central Nervous System Diseases
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Arterial Occlusive Diseases
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Pathological Conditions, Anatomical
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Constriction, Pathologic
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Carotid Stenosis
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Cardiovascular Diseases
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Carotid Artery Diseases
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Vascular Diseases
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Cerebrovascular Disorders
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Brain Diseases
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Nervous System Diseases
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Intervention(s)
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Device: Gore Embolic Filter
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Device: Gore Flow Reversal System
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Primary Outcome(s)
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Major Adverse Events (MAE)
[Time Frame: Onset from start of index procedure to 30-day follow-up assessment]
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Secondary ID(s)
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FRS 09-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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