Carotid Artery Stenosis
Conditions
Keywords
Carotid, Artery, Stenosis
Brief summary
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
Detailed description
Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.
Interventions
DEVICECarotid Artery Stenting
placement of a bare metal stent at sites of stenosis in the carotid artery
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria: * Symptomatic: \> than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure. * Asymptomatic: \> than or = to 80% carotid stenosis by angiography without neurological symptoms. * High risk for carotid endarterectomy: anatomical and co-morbid.
Exclusion criteria
* History of symptoms of stroke or TIA within 24 hours of the procedure * Extensive or diffuse atherosclerotic disease * Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Experiencing Major Adverse Events (MAE) | 365 days from implantation | A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing Access Site Complications | 30 days following implantation | Access site complications requiring blood transfusion (\> 1 unit) or open surgical repair. |
| Number of Participants Experiencing Stroke Related Neurologic Deficit | 30 days from implantation | Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure. |
| Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | 12 months from implantation | Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation |
| Number of Participants Experiencing Lesion Success | at time of implantation | number of participants experiencing achievement of \<50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System. |
| Number of Participants Experiencing Restenosis | 12 months after implantation | Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent. |
| Number of Participants Experiencing Device Success | at time of implantation | Number of participants with successful delivery and deployment of device with \<50% residual stenosis. |
Participant flow
Recruitment details
Enrollment commenced on October 7, 2005 and was completed on November 6, 2007. A total of 486 patients from 34 investigative sites within the United States were enrolled, including 79 in the roll-in cohort and 407 in the pivotal cohort. The Roll-in cohort is intended to provide initial training and verification of procedure technique
Pre-assignment details
Each site was required to enroll at least one roll-in patient prior to commencing the pivotal phase to demonstrate appropriate training and technique. Each roll-in patient was required to meet the same eligibility criteria and follow the same follow-up schedule as the pivotal cohort. The pivotal cohort represents the intent-to-treat population.
Participants by arm
| Arm | Count |
|---|---|
| ViVexx Carotid Stent Group placement of a bare metal stent for treatment of carotid artery stenosis | 486 |
| Total | 486 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 17 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Study device could not be deployed | 3 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | ViVexx Carotid Stent Group |
|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 9.14 |
| Gender Female | 191 Participants |
| Gender Male | 295 Participants |
| Region of Enrollment United States | 486 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 301 / 486 |
| serious Total, serious adverse events | 316 / 486 |
Outcome results
Primary
Percentage of Patients Experiencing Major Adverse Events (MAE)
A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.
Time frame: 365 days from implantation
Population: All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ViVexx Carotid Stent Group | Percentage of Patients Experiencing Major Adverse Events (MAE) | 6.9 percentage of participants |
Secondary
Number of Participants Experiencing Device Success
Number of participants with successful delivery and deployment of device with \<50% residual stenosis.
Time frame: at time of implantation
Population: Number of participants with successful delivery and deployment of device with \<50% residual stenosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ViVexx Carotid Stent Group | Number of Participants Experiencing Device Success | Vivexx stent success | 462 number of participants |
| ViVexx Carotid Stent Group | Number of Participants Experiencing Device Success | Emboshield device success | 462 number of participants |
Secondary
Number of Participants Experiencing Lesion Success
number of participants experiencing achievement of \<50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.
Time frame: at time of implantation
Population: number of participants with lesion success defined as \<50% residual stenosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViVexx Carotid Stent Group | Number of Participants Experiencing Lesion Success | 473 number of participants |
Secondary
Number of Participants Experiencing Restenosis
Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.
Time frame: 12 months after implantation
Population: Number of participants experiencing restenosis through 12 months from implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViVexx Carotid Stent Group | Number of Participants Experiencing Restenosis | 68 number of participants |
| Roll-in Cohort | Number of Participants Experiencing Restenosis | 43 number of participants |
Secondary
Number of Participants Experiencing Stroke Related Neurologic Deficit
Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.
Time frame: 30 days from implantation
Population: Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViVexx Carotid Stent Group | Number of Participants Experiencing Stroke Related Neurologic Deficit | 11 number of participants |
| Roll-in Cohort | Number of Participants Experiencing Stroke Related Neurologic Deficit | 1 number of participants |
| Pivotal Cohort | Number of Participants Experiencing Stroke Related Neurologic Deficit | 10 number of participants |
Secondary
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation
Time frame: 12 months from implantation
Population: Number of participants experiencing target lesion revascularization up to 12 months from implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViVexx Carotid Stent Group | Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | 19 Number of participants |
| Roll-in Cohort | Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | 2 Number of participants |
| Pivotal Cohort | Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | 17 Number of participants |
Secondary
Number of Patients Experiencing Access Site Complications
Access site complications requiring blood transfusion (\> 1 unit) or open surgical repair.
Time frame: 30 days following implantation
Population: Number of participants experiencing access site complications requiring blood transfusion (\>1 unit) or open repair.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViVexx Carotid Stent Group | Number of Patients Experiencing Access Site Complications | 8 Number of participants |
| Roll-in Cohort | Number of Patients Experiencing Access Site Complications | 1 Number of participants |
| Pivotal Cohort | Number of Patients Experiencing Access Site Complications | 7 Number of participants |