A Carotid Stenting Boston Scientific Surveillance Program - Full Text View

Sponsor:	Boston Scientific Corporation
Information provided by (Responsible Party):	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00741091

Purpose

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	Intervention	Phase
Carotid Artery Disease	Device: Carotid WALLSTENT Monorail Endoprosthesis Device: FilterWire EZ™ System™	Phase IV

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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.

Enrollment:	1097
Study Start Date:	December 2008
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741091

Show 112 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:

Pamela Grady, Ph.D

Boston Scientific Corporation

More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Oct 5.

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

Keywords provided by Boston Scientific Corporation:

Cerebrovascular Disease
Carotid Stent
Stent
Carotid Endarterectomy (CEA)

Additional relevant MeSH terms:

Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012