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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Emboshield NAV6™
Mo.Ma™
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 focused on measuring Carotid artery stenting. CGuard stent. Protection Device.

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

  • E. Meshalkin National Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))

MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)

Arm Description

183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))

183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS))

Outcomes

Primary Outcome Measures

determination of ischemic lesions
Postprocedural acute ischemic lesions (MRI)

Secondary Outcome Measures

MACCE
Death, stroke, and MI

Full Information

First Posted
February 16, 2022
Last Updated
February 16, 2022
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Chelyabinsk Regional Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05257161
Brief Title
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Acronym
SIBERIA-2
Official Title
Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Chelyabinsk Regional Clinical Hospital

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
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.

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%)
Keywords
Carotid artery stenting. CGuard stent. Protection Device.

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Arm Type
Active Comparator
Arm Description
183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Arm Title
MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)
Arm Type
Experimental
Arm Description
183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Intervention Type
Device
Intervention Name(s)
Emboshield NAV6™
Other Intervention Name(s)
Emboshield NAV6™ Embolic Protection System
Intervention Description
Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™
Intervention Type
Device
Intervention Name(s)
Mo.Ma™
Other Intervention Name(s)
Mo.Ma™ proximal cerebral protection device
Intervention Description
Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™
Primary Outcome Measure Information:
Title
determination of ischemic lesions
Description
Postprocedural acute ischemic lesions (MRI)
Time Frame
24-48 hours
Secondary Outcome Measure Information:
Title
MACCE
Description
Death, stroke, and MI
Time Frame
Intraoperatively, and within 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrey A Kaprenko, MD
Phone
+79139504100
Email
a_karpenko@meshalkin.ru
Facility Information:
Facility Name
E. Meshalkin National Medical Research Center
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey A Karpenko, MD
Email
a_karpenko@meshalkin.ru

12. IPD Sharing Statement

Citations:
PubMed Identifier
32007460
Citation
Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31855202/
Description
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Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

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