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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,097
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.
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
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).
Time frame: 30 days
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
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.
Time frame: 30 days
Target Lesion Revascularization
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.
Time frame: 30 days
System Technical Success
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.
Time frame: 30 days
Device Malfunction
Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 102 more locations
Time frame: 30 days