Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
NCT ID: NCT02915328
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-04-30
2018-04-30
Brief Summary
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The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stent Roadsaver® +Filterwire EZ™
The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection
Filterwire EZ™
Stent Roadsaver®
Stent Roadsaver® + MO.MA Ultra
The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
MO.MA Ultra
Stent Roadsaver®
Carotid Wallstent +MO.MA Ultra
The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection
MO.MA Ultra
Carotid Wallstent
Carotid Wallstent + Filterwire EZ™
The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
Filterwire EZ™
Carotid Wallstent
Interventions
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Filterwire EZ™
MO.MA Ultra
Stent Roadsaver®
Carotid Wallstent
Eligibility Criteria
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Inclusion Criteria
* symptomatic patients: \> 1.3 m/sec peak systolic velocity and \> 50% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography
* asymptomatic patients \> 2.5 m/sec peak systolic velocity and \> 70% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography
Exclusion Criteria
* contraindication to double antiplatelet treatment
* controlateral carotid occlusion
18 Years
ALL
No
Sponsors
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Centro Cardiologico Monzino
OTHER
Responsible Party
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Piero Montorsi
MD
Principal Investigators
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Piero Montorsi, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiologico Monzino, IRCCS
Locations
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Centro Cardiologico Monzino, IRCCS
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Piero Montorsi, MD
Role: primary
Stefano Galli, MD
Role: backup
References
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Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
Other Identifiers
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R323/15 - CCM334
Identifier Type: -
Identifier Source: org_study_id
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