The SIBERIA Trial (Acculink™ Versus CGuard™)

Study Overview
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Brief Summary
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That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards

Detailed Description
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Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed. Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).

Official Title
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Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial

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: Stent Acculink ™
* Device: CGuardTM™


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: Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)<br>50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM) | Device: Stent Acculink ™<br>* Carotid Artery Revascularization using Stents<br>* Other names: RX ACCULINK CAROTID STENT SYSTEM;|
| Experimental: Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))<br>50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS)) | Device: CGuardTM™<br>* Carotid Artery Revascularization using Stents<br>* Other names: The CGuardTM Embolic Prevention System (EPS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of ischemic lesions | New DW-MRI lesions post procedural their permanence at 30-days | at 30-days | 
| determination of ischemic lesions | New DW-MRI lesions post procedural (48 hours) | at 48 hours |