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.

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. 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.

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Device: Filterwire EZ™
* Device: MO.MA Ultra
* Device: Stent Roadsaver®
* Device: Carotid Wallstent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: significant, unilateral carotid artery stenosis with soft plaque defined as: 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: severe cerebral vasculopathy with cognitive impairment contraindication to double antiplatelet treatment controlateral carotid occlusion

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent Roadsaver® +Filterwire EZ™<br>The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection | Device: Filterwire EZ™<br> <br> Device: Stent Roadsaver®<br> <br> |
| Experimental: Stent Roadsaver® + MO.MA Ultra<br>The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection | Device: MO.MA Ultra<br> <br> Device: Stent Roadsaver®<br> <br> |
| Experimental: Carotid Wallstent +MO.MA Ultra<br>The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection | Device: MO.MA Ultra<br> <br> Device: Carotid Wallstent<br> <br> |
| Experimental: Carotid Wallstent + Filterwire EZ™<br>The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection | Device: Filterwire EZ™<br> <br> Device: Carotid Wallstent<br> <br> |

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 transcranial doppler | different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation | intraprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | all strokes, major and minor strokes, myocardial infarction | day 2 or day 3 and day 30 complication | 
| 6 month clinical follow up | all strokes, major and minor strokes, myocardial infarction | 6 month | 
| Doppler ultrasound assesment | stent patency and long term restenosis of target carotid artery and target vessel external carotid artery | day 2 or day 3, 1 month and 6 month |