StrokeNCT00830232
Effects of Carotid Stent Design on Cerebral Embolization
A study testing closed-cell stent (Xact stent) and Open-cell stent (Acculink carotid) in people with Stroke and Carotid Stenosis, run by Dallas VA Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Carotid Stenosis
- What is being tested?
- closed-cell stent (Xact stent) and Open-cell stent (Acculink carotid)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Stroke, Carotid Stenosis
- Being tested
- closed-cell stent (Xact stent), Open-cell stent (Acculink carotid)
- Keywords
- Stroke, Carotid stenosis, stents
- Medical subject headings
- Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-cell stent (Xact stent)Device
Also called Carotid artery angioplasty
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.
Open-cell stent (Acculink carotid)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Closed-cell stent (Xact stent) | Active comparator | For patients randomized to the closed-cell stent group, the Xact closed-cell stents were used. The Xact stent is a FDA approved device. Receives: Device: closed-cell stent (Xact stent) |
| Open-cell stent (Acculink carotid) | Active comparator | For patients randomized to the open-cell stent group, the Acculink carotid stent was used. The Acculink stent is a FDA approved device. Receives: Device: Open-cell stent (Acculink carotid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours after implantation of carotid stent
Secondary outcomes (2)
Composite of Any Stroke, Myocardial Infarction or Death
Measured: within 30 days after the carotid stenting procedure
Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI
Measured: within 24 hours after carotid artery stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Carlos H. Timaran, Dallas VA Medical Center
- Investigators
- Carlos H Timaran, MD, Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830232
- Sponsor's protocol ID
- IRB#08-035
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2009
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Timaran CH, Rosero EB, Higuera A, Ilarraza A, Modrall JG, Clagett GP. Randomized clinical trial of open-cell vs closed-cell stents for carotid stenting and effects of stent design on cerebral embolization. J Vasc Surg. 2011 Nov;54(5):1310-1316.e1; discussion 1316. doi: 10.1016/j.jvs.2011.05.013. Epub 2011 Jul 1.
PubMed 21723064
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carotid Stent Design on Cerebral Embolization
- ClinicalTrials.gov ID
- NCT00830232
- Acronym / sponsor ID
- IRB#08-035
- Conditions
- Stroke, Carotid Stenosis
- Keywords
- Stroke, Carotid stenosis, stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 27 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-cell stent (Xact stent) | Active comparator | Device: closed-cell stent (Xact stent)For patients randomized to the closed-cell stent group, the Xact closed-cell stents were used. The Xact stent is a FDA approved device. |
| Open-cell stent (Acculink carotid) | Active comparator | Device: Open-cell stent (Acculink carotid)For patients randomized to the open-cell stent group, the Acculink carotid stent was used. The Acculink stent is a FDA approved device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed-cell stent (Xact stent)Also: Carotid artery angioplastyPatients 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. | Device | Closed-cell stent (Xact stent) |
| Open-cell stent (Acculink carotid)Also: Carotid artery angioplastyPatients 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. | Device | Open-cell stent (Acculink carotid) |
Primary outcome
Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.
Time frame: 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.
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21723064Timaran CH, Rosero EB, Higuera A, Ilarraza A, Modrall JG, Clagett GP. Randomized clinical trial of open-cell vs closed-cell stents for carotid stenting and effects of stent design on cerebral embolization. J Vasc Surg. 2011 Nov;54(5):1310-1316.e1; discussion 1316. doi: 10.1016/j.jvs.2011.05.013. Epub 2011 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos H Timaran, MD principal investigator
Dallas VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed-cell stent (Xact stent) and Open-cell stent (Acculink carotid) in people with Stroke and Carotid Stenosis, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. (time frame: First 24 hours after implantation of carotid stent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.