GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN) (EMBOLDEN)
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|ClinicalTrials.gov Identifier: NCT00766493|
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : August 7, 2012
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: GORE® Embolic Filter||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Experimental: GORE® Embolic Filter
Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.
Device: GORE® Embolic Filter
Embolic protection during carotid stenting
- Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure [ Time Frame: 30 days ]
- Device Success [ Time Frame: Post Procedure ]Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).
- Clinical Success [ Time Frame: 30 days ]Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.
- Access Site Complications [ Time Frame: 30 days ]Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.
- Neurologic Events [ Time Frame: 30 days ]Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766493
|Principal Investigator:||William A. Gray, MD||Columbia University|