Clinical Trial: A Carotid Stenting Boston Scientific Surveillance Program

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

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.

Detailed Summary:
Sponsor: Boston Scientific Corporation

Current Primary Outcome: 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).


Original Primary Outcome: Composite of major adverse events (MAE) defined as center-reported and CEC adjudicated death, stroke, and myocardial infarction (MI) [ Time Frame: 30 days ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Device, procedure, and unrelated adverse events [ Time Frame: 30 days ]
  • Target Lesion Revascularization [ Time Frame: 30 days ]
  • System Technical Success [ Time Frame: 30 days ]
  • Device Malfunction [ Time Frame: 30 days ]


Information By: Boston Scientific Corporation

Dates:
Date Received: August 25, 2008
Date Started: December 2008
Date Completion:
Last Updated: August 22, 2011
Last Verified: August 2011