Actively Recruiting
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Led by Meshalkin Research Institute of Pathology of Circulation · Updated on 2022-02-25
366
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
M
Meshalkin Research Institute of Pathology of Circulation
Lead Sponsor
F
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 80 years
- Accepted for carotid artery stenting after neurological consultation and qualification
- Life expectancy longer than 6 months
- Suitable clinical condition for diffusion-weighted MRI
- Provided written informed consent approved by Ethics Committee
- Agrees to complete all required follow-up procedures and visits
You will not qualify if you...
- Enrolled in another investigational device or drug study that is not completed or interferes with this study
- Recent surgery within 30 days before or planned surgery within 30 days after stenting
- Active liver disease (bilirubin > 35 mmol/l) or kidney insufficiency (creatinine > 2.5 mg/dL or glomerular filtration rate < 60 ml/min)
- Recent evolving acute stroke within 30 days prior to evaluation
- Myocardial infarction within 72 hours before stenting (CPK-MB > 3 times normal)
- Female patients of childbearing potential or known pregnancy
- Known stroke causes other than carotid stenosis, such as atrial fibrillation, atrial flutter, or thrombophilia
- Patient taking vitamin K antagonists or new oral anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
E. Meshalkin National Medical Research Center
Novosibirsk, Russia
Actively Recruiting
Research Team
A
Andrey A Kaprenko, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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