Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

Study Overview
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Brief Summary
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The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.

Official Title
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Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS

Conditions
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Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)

Intervention / Treatment
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* Device: Emboshield NAV6™
* Device: Mo.Ma™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice. More than 6-month life expectancy Suitable clinical conditions for performing DW-MRI Written Informed consent approved by the Ethics Committee Subject agrees to all required follow-up procedures and visits Exclusion Criteria: Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min) Recent evolving acute stroke within 30-days of study evaluation Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal) Female patients of childbearing potential or known to be pregnant Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia Patient on VKA or new oral anticoagulants

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))<br>183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Device: Emboshield NAV6™<br>* Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™<br>* Other names: Emboshield NAV6™ Embolic Protection System;|
| Experimental: MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)<br>183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Device: Mo.Ma™<br>* Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™<br>* Other names: Mo.Ma™ proximal cerebral protection device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of ischemic lesions | Postprocedural acute ischemic lesions (MRI) | 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Death, stroke, and MI | Intraoperatively, and within 48 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid artery stenting. CGuard stent. Protection Device.