NCT05257161

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2021Jan 2027

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

5 years

First QC Date

February 16, 2022

Last Update Submit

February 16, 2022

Conditions

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

Keywords

Carotid artery stenting. CGuard stent. Protection Device.

Outcome Measures

Primary Outcomes (1)

  • determination of ischemic lesions

    Postprocedural acute ischemic lesions (MRI)

    24-48 hours

Secondary Outcomes (1)

  • MACCE

    Intraoperatively, and within 48 hours.

Study Arms (2)

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

ACTIVE COMPARATOR

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

Device: Emboshield NAV6™

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

EXPERIMENTAL

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

Device: Mo.Ma™

Interventions

Emboshield NAV6™DEVICE

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

Also known as: Emboshield NAV6™ Embolic Protection System
Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Mo.Ma™DEVICE

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

Also known as: Mo.Ma™ proximal cerebral protection device
MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32007460RESULT

Related Links

Central Study Contacts

Andrey A Kaprenko, MD

CONTACT

+79139504100a_karpenko@meshalkin.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

November 1, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

RU(1)