Carotid Stenosis, Stroke
Conditions
Keywords
Stroke, Carotid stenosis, stents
Brief summary
The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).
Detailed description
Stroke is responsible for more than 10% of all deaths and much severe disability in developed countries. In the United States, approximately 600,000 new strokes are reported annually, of which 150,000 are fatal, and more than 4,000,000 surviving stroke victims are affected by significant disability. Seventy-five percent of strokes occur in the distribution of the carotid arteries and are considered of a thromboembolic etiology, most of which originate in carotid lesions. Carotid artery stenting (CAS) with cerebral embolic protection is currently the preferred treatment of carotid stenosis in high risk surgical patients, i.e., those with significant comorbidities or a hostile neck from previous surgical procedures or radiation. Although several predictors of adverse outcomes after CAS have been identified, the effects of device characteristics, including stent design, on neurologic adverse events have not been established. The proposed study will be a randomized prospective controlled trial designed to test the hypothesis that the implantation of closed-cell stents for carotid lesions in high-risk patients will be associated with a reduced perioperative cerebral microembolization, as detected by transcranial Doppler and diffusion-weighted magnetic resonance imaging of the brain, and reduced 30-day stroke, myocardial infarction, and death rates when compared with the implantation of open-cell stents.
Interventions
DEVICEclosed-cell stent (Xact stent)
Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this groups was the Xact closed-cell stent. This type of device is rigid device with dense conposition of the nitinol rigns. Carotid stenting was used on standard fashion using filters as embolic protection device.
DEVICEOpen-cell stent (Acculink carotid)
Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent. Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device.
Sponsors
Dallas VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND * Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR * Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology
Exclusion criteria
* Conditions that interfere with the evaluation of endpoints * Subject has anticipated or potential sources of cardiac emboli * Subject plans to have a major surgical procedure within 30 days after the index procedure. * Subject has intracranial pathology that makes the subject inappropriate for study participation. * Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA). * Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent. * Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. | First 24 hours after implantation of carotid stent | Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal. |
Secondary
| Measure | Time frame |
|---|---|
| Composite of Any Stroke, Myocardial Infarction or Death | within 30 days after the carotid stenting procedure |
| Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI | within 24 hours after carotid artery stenting |
Countries
United States
Participant flow
Recruitment details
Patients recruitment was started on december 2008 and continued until February 2012. Patients recruitment and consenting were performed at the medical clinic.
Pre-assignment details
Patients were considered officially enrolled after the randomization, which was performed during the procedure after the initial angiography (initial image of the brain blood flow).
Participants by arm
| Arm | Count |
|---|---|
| Closed-cell Stent closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes. | 20 |
| Open-cell Stent Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Open-cell Stent | Closed-cell Stent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 13 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 8.5 | 66 years STANDARD_DEVIATION 8.07 | 66.7 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 7 / 20 | 4 / 20 |
Outcome results
Primary
Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.
Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.
Time frame: First 24 hours after implantation of carotid stent
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed-cell Stent | Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. | 264 Micro-emboli |
| Open-cell Stent | Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. | 339 Micro-emboli |
Secondary
Composite of Any Stroke, Myocardial Infarction or Death
Time frame: within 30 days after the carotid stenting procedure
Secondary
Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI
Time frame: within 24 hours after carotid artery stenting