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A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00741091
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : August 19, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.

Condition or disease Intervention/treatment Phase
Carotid Artery Disease Device: Carotid WALLSTENT Monorail Endoprosthesis Device: FilterWire EZ™ System™ Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1097 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Registry
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
  • Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR
  • Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.
  • Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.
  • Subject is willing and able to comply with all follow-up requirements.
  • Subject has provided a signed informed consent prior to participation in the Registry.

Exclusion Criteria:

  • Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
  • Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
  • Patients with uncorrected bleeding disorders
  • Lesions in the ostium of the common carotid artery.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Pamela Grady, Ph.D Boston Scientific Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00741091    
Other Study ID Numbers: S2029
First Posted: August 26, 2008    Key Record Dates
Results First Posted: August 19, 2011
Last Update Posted: August 24, 2011
Last Verified: August 2011
Keywords provided by Boston Scientific Corporation:
Cerebrovascular Disease
Carotid Stent
Stent
Carotid Endarterectomy (CEA)
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases