Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS (SIBERIA-2)

February 16, 2022 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))
183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Device: Emboshield NAV6™
Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™
Other Names:
  • Emboshield NAV6™ Embolic Protection System
Experimental: MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)
183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Device: Mo.Ma™
Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™
Other Names:
  • Mo.Ma™ proximal cerebral protection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of ischemic lesions
Time Frame: 24-48 hours
Postprocedural acute ischemic lesions (MRI)
24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE
Time Frame: Intraoperatively, and within 48 hours.
Death, stroke, and MI
Intraoperatively, and within 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Collaborators

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Chelyabinsk Regional Clinical Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIBERIA 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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