- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274676
Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque") (MOMA)
January 10, 2011 updated by: Centro Cardiologico Monzino
Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20138
- Centro Cardiologico Monzino, IRCCS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-patients with monolateral, significant, soft carotid stenosis
Exclusion Criteria:
- patients with controlateral carotid occlusion
- patients with critic stenosis of the external carotid
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: carotid stenting with MOMA
|
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.
Other Names:
|
Active Comparator: Carotid stenting with filter wire EZ
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of Microembolization signals (MES) detected with transcranal doppler
Time Frame: 6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
|
6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success
Time Frame: In hospital and 30 days
|
Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).
|
In hospital and 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
January 10, 2011
First Posted (Estimate)
January 11, 2011
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S111/508
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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