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

August 25, 2008
August 22, 2011
December 2008
October 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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).
Composite of major adverse events (MAE) defined as center-reported and CEC adjudicated death, stroke, and myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00741091 on ClinicalTrials.gov Archive Site
  • Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
  • Device, procedure, and unrelated adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • System technical success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Device Malfunction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Carotid Stenting Boston Scientific Surveillance Program
A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carotid Artery Disease
  • 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.
Experimental: Registry
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Interventions:
  • Device: Carotid WALLSTENT Monorail Endoprosthesis
  • Device: FilterWire EZ™ System™
White CJ, Avula SB, Mintz RT, Iskander A, Chervu A, Feldman RL, Schermerhorn ML, Woo HH, Hopkins LN. Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):167-73. doi: 10.1002/ccd.23257. Epub 2011 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1097
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00741091
S2029
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Pamela Grady, Ph.D Boston Scientific Corporation
Boston Scientific Corporation
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP