Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country366 target enrollmentNovember 1, 2021

ConditionsPatients With Aterosclerotic Carotid Stenosis Symptomatic Patients (Stenosis > 50%)Asymptomatic Patients (Stenosis ≥80%)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients With Aterosclerotic Carotid Stenosis
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 366
Locations: 1
Primary Endpoint: determination of ischemic lesions
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 for a difference between the proximal and distal anti-embolic device for the CGuard stent.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

January 1, 2027

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

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