Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque") (MOMA)
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|ClinicalTrials.gov Identifier: NCT01274676|
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis||Device: carotid stenting with MOMA Device: Carotid stenting with filter wire EZ||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Active Comparator: carotid stenting with MOMA||
Device: 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 Name: MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY)
|Active Comparator: Carotid stenting with filter wire EZ||
Device: 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 Name: Filterwire EZ - Boston Scientific
- 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 ]
- Clinical success [ Time Frame: In hospital and 30 days ]Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274676
|Centro Cardiologico Monzino, IRCCS|
|Milan, Italy, 20138|
|Principal Investigator:||Piero Montorsi, MD||Centro Cardiologico Monzino, IRCCS|