The SIBERIA Trial (Acculink™ Versus CGuard™) (CAS)

September 30, 2021 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

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 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: Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)
50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)
Device: Stent Acculink ™
Carotid Artery Revascularization using Stents
Other Names:
  • RX ACCULINK CAROTID STENT SYSTEM
Experimental: Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))
50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS))
Device: CGuardTM™
Carotid Artery Revascularization using Stents
Other Names:
  • The CGuardTM Embolic Prevention System (EPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of ischemic lesions
Time Frame: at 30-days
New DW-MRI lesions post procedural their permanence at 30-days
at 30-days
determination of ischemic lesions
Time Frame: at 48 hours
New DW-MRI lesions post procedural (48 hours)
at 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

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

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)

September 11, 2017

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

March 9, 2021

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRICP 9872

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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