Status:
RECRUITING
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Collaborating Sponsors:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Chelyabinsk Regional Clinical Hospital
Conditions:
Patients With Aterosclerotic Carotid Stenosis
Symptomatic Patients (Stenosis > 50%)
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT05257161
Start Date
November 1 2021
End Date
January 1 2027
Last Update
February 25 2022
Active Locations (1)
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1
E. Meshalkin National Medical Research Center
Novosibirsk, Russia