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

RecruitingNAAges 45 Years - 80 YearsAllMeshalkin Research Institute of Pathology of Circ…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria 1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice. 2. More than 6-month life expectancy 3. Suitable clinical conditions for performing DW-MRI 4. Written Informed consent approved by the Ethics Committee 5. Subject agrees to all required follow-up procedures and visits Exclusion Criteria: 1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints 2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure 3. Hepatic active disease (bilirubin\> 35 mmol / l) or renal insufficiency (serum creatinine \> 2.5 mg/dL or glomerular filtration rate \<60 ml / min) 4. Recent evolving acute stroke within 30-days of study evaluation 5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \> 3 times normal) 6. Female patients of childbearing potential or known to be pregnant 7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia 8. Patient on VKA or new oral anticoagulants
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What it tests

  • Emboshield NAV6™
  • Mo.Ma™
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Where

1 site
E. Meshalkin National Medical Research Center
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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