Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque")
MOMA
Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque
1 other identifier
interventional
53
1 country
1
Brief Summary
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication. Thanks to the systematic use of cerebral protection systems, these complications have reduced.A debate concerning which cerebral protective device should be more effective is still ongoing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedJanuary 11, 2011
September 1, 2009
1 year
January 10, 2011
January 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of Microembolization signals (MES) detected with transcranal doppler
6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
Secondary Outcomes (1)
Clinical success
In hospital and 30 days
Study Arms (2)
carotid stenting with MOMA
ACTIVE COMPARATORCarotid stenting with filter wire EZ
ACTIVE COMPARATORInterventions
The MOMA system is an endovascular catheter for proximal protection during carotid stenting. The system allows a concomitant balloon occlusion of both external and common carotid arteries leading to blood flow reversal within the internal carotid artery.
The filter wire EZ a distal protection system that is placed in he distal internal carotid artery before carotid stenting. The filter should entrap almost all the debries that are generated during endovascular procedure. At the end of the procedure the filter is retrieved throught a dedicated retrieval catheter.
Eligibility Criteria
You may qualify if:
- patients with monolateral, significant, soft carotid stenosis
You may not qualify if:
- patients with controlateral carotid occlusion
- patients with critic stenosis of the external carotid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Cardiologico Monzino, IRCCS
Milan, 20138, Italy
Related Publications (1)
Montorsi P, Caputi L, Galli S, Ciceri E, Ballerini G, Agrifoglio M, Ravagnani P, Trabattoni D, Pontone G, Fabbiocchi F, Loaldi A, Parati E, Andreini D, Veglia F, Bartorelli AL. Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection. J Am Coll Cardiol. 2011 Oct 11;58(16):1656-63. doi: 10.1016/j.jacc.2011.07.015.
PMID: 21982309DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piero Montorsi, MD
Centro Cardiologico Monzino, IRCCS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2011
First Posted
January 11, 2011
Study Start
February 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
January 11, 2011
Record last verified: 2009-09