Phase 4
N=1,097
A Carotid Stenting Boston Scientific Surveillance Program
Carotid Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00741091 ↗Enrolled (actual)
1,097
Serious AEs
21.0%
Results posted
Aug 2011
Primary outcome: Primary: Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) — 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Carotid WALLSTENT Monorail Endoprosthesis (Device); FilterWire EZ™ System™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) |
47 | — |
| SECONDARY Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) |
139; 486; 390 | — |
| SECONDARY Target Lesion Revascularization |
— | — |
| SECONDARY System Technical Success |
1041 | — |
| SECONDARY Device Malfunction |
61 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00741091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.