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NCT Number: NCT05257161

Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal 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.

Recruiting

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

Location status: Recruiting

Location contact

Andrey A Karpenko, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emboshield NAV6™

Device

Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™

Other names: Emboshield NAV6™ Embolic Protection System

Mo.Ma™

Device

Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™

Other names: Mo.Ma™ proximal cerebral protection device

Primary outcomes

  1. determination of ischemic lesions

    Time frame: 24-48 hours

    Postprocedural acute ischemic lesions (MRI)

Secondary outcomes

  1. MACCE

    Time frame: Intraoperatively, and within 48 hours.

    Death, stroke, and MI

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey A Kaprenko, MD

CONTACT

[email protected]

+79139504100

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Collaborators

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

Registry information

Official study title

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

Acronym: SIBERIA-2

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2022
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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