Carotid Stenting in Patients With High Risk Carotid Stenosis (Soft Plaque)

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Device: carotid stenting with MOMA
* Device: Carotid stenting with filter wire EZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -patients with monolateral, significant, soft carotid stenosis Exclusion Criteria: patients with controlateral carotid occlusion patients with critic stenosis of the external carotid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carotid stenting with MOMA<br> | Device: carotid stenting with MOMA<br>* 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.<br>* Other names: MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY);|
| Active Comparator: Carotid stenting with filter wire EZ<br> | Device: Carotid stenting with filter wire EZ<br>* 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.<br>* Other names: Filterwire EZ - Boston Scientific;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction). | In hospital and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stenting, carotid plaque, stenosis, angioplasty