A Carotid Stenting Boston Scientific Surveillance Program

Phase 4

Completed

• Conditions: Carotid Artery Disease
• Interventions: Device: Carotid WALLSTENT Monorail Endoprosthesis; Device: FilterWire EZ™ System™

• Registration Number: NCT00741091
• Lead Sponsor: Boston Scientific Corporation

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 Description

Not available

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Study Start: 2008-12
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-06-02
• Results First Submitted QC: 2011-07-25
• Status Verified: 2011-08
• Results First Posted: 2011-08-19
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1097

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Registry	Carotid WALLSTENT Monorail Endoprosthesis	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Registry	FilterWire EZ™ System™	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)	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	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	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	30 days	Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.

Trial Locations

Locations (111)

Baptist Medical Center Princeton; 🇺🇸 Birmingham, Alabama, United States

Cardiology Associates of Mobile; 🇺🇸 Fairhope, Alabama, United States

St. Joseph's Hospital and Medical Center, Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Southern Arizona Vascular Institute; 🇺🇸 Tucson, Arizona, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Central Cardiology Medical Clinic; 🇺🇸 Bakersfield, California, United States

Los Angeles Cardiology Associates; 🇺🇸 Los Angeles, California, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Hoag Hospital; 🇺🇸 Newport Beach, California, United States

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

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