Carotid Artery StenosisNCT01550835
Impact of Aspiration Thrombectomy During Carotid Stenting
A study testing Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) in people with Carotid Artery Stenosis, run by Fogarty Clinical Research Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICA stenosis greater than 50 percent by carotid angiography
- Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion
Who cannot join
- Subject less than 40 years of age
- Pregnant subjects
- Asymptomatic carotid stenosis
- Total occlusion of target carotid artery
- Inability to deploy distal protection device or stent in target vessel
- Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)
Show all 24Show fewer
- Multiple carotid stenoses in same vessel that cannot be covered by single stent
- Ipsilateral intracranial stenosis requiring treatment
- Isolated common carotid stenosis
- Stenosis less than 50 percent by angiography
- Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.
- Life expectancy less than 30 days
- Active bleeding diathesis
- Suspected Myocardial Infarction within 72 hours prior to carotid stenting
- Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment
- Inability to undergo DWMRI
- Unwillingness to participate or provide consent
- Subjects using a legally authorized representative for consent for participation
- Concurrently enrolled in another study
- Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization
- Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch
- Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries
- Prior large stroke, multiple lacunar infarcts, or dementia
- Stenosis that contain visible thrombus
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
El Camino Hospital
Mountain View, California, 94040
Betty deBettencourt, RN, 650-962-4566, betty.debettencourt@fogartyinstitute.org
James Joye, DO
- Recruiting
Northern Michigan Regional Hospital
Petoskey, Michigan, 49770
Jennifer Lalonde, RN, 231-487-9185, jlalonde@cvrcnm.com
Jason Ricci, MD
About this study
Official title: Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.
Read the detailed description
Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
- Keywords
- Symptomatic carotid artery stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Device
Standard of care use of an embolic protection device
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Device
Aspiration thrombectomy following stent deployment and prior to embolic protection device removal
| Study group | Role | What they receive |
|---|---|---|
| Distal Embolic Protection Only | Experimental | Carotid stenting with distal embolic protection only Receives: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) |
| Distal embolic protection and aspiration thrombectomy | Active comparator | Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection Receives: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new, ischemic foci
Foci of restricted diffusion will be classified by their number, location, and size
Measured: 18-48 hours post procedure
Secondary outcomes (1)
Ischemic zone area
Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain
Measured: 18-48 hours post stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fogarty Clinical Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Helen Kay Foundation, Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
- Responsible party
- Principal investigator, James Joye, Fogarty Clinical Research Inc.
- Investigators
- James Joye, DO, Principal investigator, Fogarty Clinical Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550835
- Sponsor's protocol ID
- EV-10322
- Status last verified
- Apr 2015
- First submitted
- 1 Mar 2012
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01550835
- Acronym / sponsor ID
- EV-10322
- Conditions
- Carotid Artery Stenosis
- Keywords
- Symptomatic carotid artery stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fogarty Clinical Research Inc.University, hospital or other
- Collaborators
- Abbott Medical Devices, Helen Kay Foundation, Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (estimated)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.
Detailed description
Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal Embolic Protection Only | Experimental | Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Carotid stenting with distal embolic protection only |
| Distal embolic protection and aspiration thrombectomy | Active comparator | Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICA stenosis greater than 50 percent by carotid angiography
- Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion
Key exclusion criteria (24 listed)
- Subject less than 40 years of age
- Pregnant subjects
- Asymptomatic carotid stenosis
- Total occlusion of target carotid artery
- Inability to deploy distal protection device or stent in target vessel
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 |
|---|---|---|
| Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Standard of care use of an embolic protection device | Device | Distal Embolic Protection Only |
| Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)Aspiration thrombectomy following stent deployment and prior to embolic protection device removal | Device | Distal embolic protection and aspiration thrombectomy |
Primary outcome
Number of new, ischemic foci
Time frame: 18-48 hours post procedure
Foci of restricted diffusion will be classified by their number, location, and size
1 secondary outcome
Ischemic zone area
Time frame: 18-48 hours post stenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
James Joye, DO principal investigator
Fogarty Clinical Research Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA) in people with Carotid Artery Stenosis, run by Fogarty Clinical Research Inc. at 2 sites 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 2 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Betty deBettencourt, RN (650-962-4566, betty.debettencourt@fogartyinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new, ischemic foci (time frame: 18-48 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2015.