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

Sponsor
Meshalkin Research Institute of Pathology of Circulation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05257161
Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (Other), Chelyabinsk Regional Clinical Hospital (Other)
366
Enrollment
1
Location
2
Arms
62
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Emboshield NAV6™
  • Device: Mo.Ma™
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. determination of ischemic lesions [24-48 hours]

      Postprocedural acute ischemic lesions (MRI)

    Secondary Outcome Measures

    1. MACCE [Intraoperatively, and within 48 hours.]

      Death, stroke, and MI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 E. Meshalkin National Medical Research Center Novosibirsk Russian Federation

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Meshalkin Research Institute of Pathology of Circulation
    ClinicalTrials.gov Identifier:
    NCT05257161
    Other Study ID Numbers:
    • SIBERIA 2
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meshalkin Research Institute of Pathology of Circulation
    Carotid artery stenting. CGuard stent. Protection Device.
    Additional relevant MeSH terms:
    Carotid Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Feb 25, 2022