Carotid Artery Disease
Conditions
Keywords
Cerebrovascular Disease, Carotid Stent, Stent, Carotid Endarterectomy (CEA)
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.
Interventions
DEVICECarotid 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.
DEVICEFilterWire EZ™ System™
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment began on 17 December 2008. Enrollment was completed on 28 September 2010.
Participants by arm
| Arm | Count |
|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice. | 1,097 |
| Total | 1,097 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 13 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Missed Visit | 22 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Carotid WALLSTENT Endoprothesis and FilterWire EZ System |
|---|---|
| Age Continuous | 71.3 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 1097 participants |
| Sex: Female, Male Female | 414 Participants |
| Sex: Female, Male Male | 683 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 332 / 1,097 |
| serious Total, serious adverse events | 230 / 1,097 |
Outcome results
Primary
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
Population: All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) | 47 Participants |
Secondary
Device Malfunction
Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Device Malfunction | 61 Devices |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) | Participants with Device Related AEs | 139 Participants |
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) | Participants with Procedure Related AEs | 486 Participants |
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) | Participants with Unrelated AEs | 390 Participants |
Secondary
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
Population: To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | System Technical Success | 1041 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carotid WALLSTENT Endoprothesis and FilterWire EZ System | Target Lesion Revascularization | 0 Participants |