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

Primary Purpose

Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Stent Acculink ™
CGuardTM™
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Aterosclerotic Carotid Stenosis

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andrey A. Karpenko

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)

Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))

Arm Description

50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)

50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS))

Outcomes

Primary Outcome Measures

determination of ischemic lesions
New DW-MRI lesions post procedural their permanence at 30-days
determination of ischemic lesions
New DW-MRI lesions post procedural (48 hours)

Secondary Outcome Measures

Full Information

First Posted
September 12, 2017
Last Updated
September 30, 2021
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT03488199
Brief Title
The SIBERIA Trial (Acculink™ Versus CGuard™)
Acronym
CAS
Official Title
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)
Arm Type
Active Comparator
Arm Description
50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)
Arm Title
Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Arm Type
Experimental
Arm Description
50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS))
Intervention Type
Device
Intervention Name(s)
Stent Acculink ™
Other Intervention Name(s)
RX ACCULINK CAROTID STENT SYSTEM
Intervention Description
Carotid Artery Revascularization using Stents
Intervention Type
Device
Intervention Name(s)
CGuardTM™
Other Intervention Name(s)
The CGuardTM Embolic Prevention System (EPS)
Intervention Description
Carotid Artery Revascularization using Stents
Primary Outcome Measure Information:
Title
determination of ischemic lesions
Description
New DW-MRI lesions post procedural their permanence at 30-days
Time Frame
at 30-days
Title
determination of ischemic lesions
Description
New DW-MRI lesions post procedural (48 hours)
Time Frame
at 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Andrey A. Karpenko
City
Novosibirsk
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
34736737
Citation
Karpenko A, Bugurov S, Ignatenko P, Starodubtsev V, Popova I, Malinowski K, Musialek P. Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2377-2387. doi: 10.1016/j.jcin.2021.08.005.
Results Reference
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The SIBERIA Trial (Acculink™ Versus CGuard™)

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