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

Launched by MESHALKIN RESEARCH INSTITUTE OF PATHOLOGY OF CIRCULATION · Feb 16, 2022

Keywords

ClinConnect Summary

The SIBERIA study is looking at a new type of stent, called the CGuard, which is used to treat patients with narrowed arteries in the neck caused by a condition known as carotid stenosis. This trial aims to compare the early outcomes of using this stent with different types of protective devices that help prevent strokes during the procedure. It’s important because it could help doctors understand the best way to use the CGuard stent to keep patients safe.

To participate in this study, you need to be between 45 and 80 years old and have been approved for the stenting procedure based on your medical evaluation. You'll also need to be in good enough health to undergo an MRI test and agree to all follow-up appointments. Participants can expect to receive the CGuard stent and will be monitored closely to see how well it works and whether there are any complications. The study is currently recruiting participants, and it is crucial for anyone interested to talk with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• • 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