A Carotid Stenting Boston Scientific Surveillance Program (CABANA)
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|ClinicalTrials.gov Identifier: NCT00741091|
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : August 19, 2011
Last Update Posted : August 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Disease||Device: Carotid WALLSTENT Monorail Endoprosthesis Device: FilterWire EZ™ System™||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1097 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Device: Carotid WALLSTENT Monorail Endoprosthesis
A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
Device: FilterWire EZ™ System™
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
- Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) [ Time Frame: 30 days ]Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
- Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) [ Time Frame: 30 days ]Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
- Target Lesion Revascularization [ Time Frame: 30 days ]Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
- System Technical Success [ Time Frame: 30 days ]System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
- Device Malfunction [ Time Frame: 30 days ]Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
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): NCT00741091
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|Study Director:||Pamela Grady, Ph.D||Boston Scientific Corporation|