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Completed

NCT Number: NCT03488199

The SIBERIA Trial (Acculink™ Versus CGuard™)

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

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andrey A. Karpenko

Novosibirsk, Russia

About this study

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).

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

Stent Acculink ™

Device

Carotid Artery Revascularization using Stents

Other names: RX ACCULINK CAROTID STENT SYSTEM

CGuardTM™

Device

Carotid Artery Revascularization using Stents

Other names: The CGuardTM Embolic Prevention System (EPS)

Primary outcomes

  1. determination of ischemic lesions

    Time frame: at 30-days

    New DW-MRI lesions post procedural their permanence at 30-days

  2. determination of ischemic lesions

    Time frame: at 48 hours

    New DW-MRI lesions post procedural (48 hours)

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Acronym: CAS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2018
Registry last updated
Oct 8, 2021

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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