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A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00741091
First received: August 25, 2008
Last updated: August 22, 2011
Last verified: August 2011
Results First Received: June 2, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carotid Artery Disease
Interventions: Device: Carotid WALLSTENT Monorail Endoprosthesis
Device: FilterWire EZ™ System™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began on 17 December 2008. Enrollment was completed on 28 September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Carotid WALLSTENT Endoprothesis and FilterWire EZ System Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Participant Flow:   Overall Study
    Carotid WALLSTENT Endoprothesis and FilterWire EZ System  
STARTED     1097  
COMPLETED     1040  
NOT COMPLETED     57  
Death                 13  
Lost to Follow-up                 16  
Withdrawal by Subject                 6  
Missed Visit                 22  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Carotid WALLSTENT Endoprothesis and FilterWire EZ System Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Baseline Measures
    Carotid WALLSTENT Endoprothesis and FilterWire EZ System  
Number of Participants  
[units: participants]
  1097  
Age  
[units: years]
Mean ± Standard Deviation
  71.3  ± 9.2  
Gender  
[units: participants]
 
Female     414  
Male     683  
Region of Enrollment  
[units: participants]
 
United States     1097  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)   [ Time Frame: 30 days ]

3.  Secondary:   Target Lesion Revascularization   [ Time Frame: 30 days ]

4.  Secondary:   System Technical Success   [ Time Frame: 30 days ]

5.  Secondary:   Device Malfunction   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Todd Kornmann, Specialist, Prin Reg Affairs
Organization: Boston Scientific Corporation
phone: 763-494-1348
e-mail: Todd.Kornmann@bsci.com


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00741091     History of Changes
Other Study ID Numbers: S2029
Study First Received: August 25, 2008
Results First Received: June 2, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board