An interventional study of closed-cell stent (Xact stent) and Open-cell stent (Acculink carotid) in Stroke and Carotid Stenosis, sponsored by Dallas VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Dallas VA Medical Center · Not applicable, Interventional, and Prevention
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).
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.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 40 is below the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Dallas VA Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
For patients randomized to the closed-cell stent group, the Xact closed-cell stents were used. The Xact stent is a FDA approved device.
Device: closed-cell stent (Xact stent)
For patients randomized to the open-cell stent group, the Acculink carotid stent was used. The Acculink stent is a FDA approved device.
Device: Open-cell stent (Acculink carotid)
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.
Also known as: Carotid artery angioplasty
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.
Also known as: Carotid artery angioplasty
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
Composite of Any Stroke, Myocardial Infarction or Death
Time frame: within 30 days after the carotid stenting procedure
Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI
Time frame: within 24 hours after carotid artery stenting
Patients recruitment was started on december 2008 and continued until February 2012. Patients recruitment and consenting were performed at the medical clinic.
| Milestone | Closed-cell Stent | Open-cell Stent |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| Micro-emboli | Closed-cell Stent | Open-cell Stent |
|---|---|---|
| Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. | 264 (222 to 343) | 339 (163 to 408) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Assessment for adverse events was perfumed at 30 days after carotid stenting.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Closed-cell Stent | — | 7/20 (35%) | — |
| Open-cell Stent | — | 4/20 (20%) | — |
| Event | Closed-cell Stent | Open-cell Stent |
|---|---|---|
| Peri-operative hypotensionVascular disorders | 3/20 | 0/20 |
| Non-ST elevation myocardial infarction (NSTEMI)Cardiac disorders | 2/20 | 0/20 |
| Groin HematomaVascular disorders | 0/20 | 1/20 |
| AphasiaNervous system disorders | 0/20 | 1/20 |
| AnginaCardiac disorders | 1/20 | 0/20 |
| StrokeVascular disorders | 0/20 | 1/20 |
| Transient Ischemic AtackNervous system disorders | 0/20 | 1/20 |
| NephrolithiasisRenal and urinary disorders | 1/20 | 0/20 |
| Age, Categorical(Participants) | Closed-cell Stent | Open-cell Stent | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 5 | 12 |
| >=65 years | 13 | 15 | 28 |
| Age, Continuous(years) | Closed-cell Stent | Open-cell Stent | Total |
|---|---|---|---|
| Mean | 66 ± 8.07 | 67 ± 8.5 | 66.7 ± 8.2 |
| Sex: Female, Male(Participants) | Closed-cell Stent | Open-cell Stent | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 17 | 19 | 36 |
| Region of Enrollment(participants) | Closed-cell Stent | Open-cell Stent | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Dallas VA Medical Center