The SIBERIA Trial (Acculink™ Versus CGuard™)

Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial

NCT03488199•Meshalkin Research Institute of Pathology of Circulation

View on ClinicalTrials.gov

Summary

That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards

Detailed Description

Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed. Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Andrey A. Karpenko

Novosibirsk, Russia

Key Dates

Start Date

September 11, 2017

Primary Completion Date

February 11, 2021

Completion Date

March 9, 2021

Last Updated

October 8, 2021

Enrollment

100

ACTUAL participants

Conditions

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

Interventions

Stent Acculink ™

DEVICE

CGuardTM™

DEVICE