Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With … (NCT05257161) | Clinical Trial Compass
RecruitingNot Applicable
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Russia366 participantsStarted 2021-11-01
Plain-language summary
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.
Who can participate
Age range45 Years – 80 Years
SexALL
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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
What they're measuring
1
determination of ischemic lesions
Timeframe: 24-48 hours
Trial details
NCT IDNCT05257161
SponsorMeshalkin Research Institute of Pathology of Circulation