A Carotid Stenting Boston Scientific Surveillance Program - Full Text View

Sponsor:	Boston Scientific Corporation
Information provided by:	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:	Treatment, Open Label, Single Group Assignment
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 CEC adjudicated death, stroke, and myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Device, procedure, and unrelated adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Target lesion revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
System technical success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Device Malfunction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1100
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Registry: Experimental 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

Registry: Experimental

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

Contacts

Contact: Roni Pettigrew

651-581-4683

Veronica.Pettigrew@bsci.com

Show 106 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:

Pamela Grady, Ph.D

Boston Scientific Corporation

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation ( Roni Pettigrew / Project Manager )
Study ID Numbers:	S2029
Study First Received:	August 25, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00741091 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Cerebrovascular Disease
Carotid Stent
Stent
CEA
Carotid Endarterectomy

Additional relevant MeSH terms:

Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010