Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05257161

Acronym

SIBERIA-2

Enrollment

366

Registered

2022-02-25

Start date

2021-11-01

Completion date

2027-01-01

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Carotid artery stenting. CGuard stent. Protection Device.

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.

Interventions

DEVICEEmboshield NAV6™

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

DEVICEMo.Ma™

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
determination of ischemic lesions	24-48 hours	Postprocedural acute ischemic lesions (MRI)

Secondary

Measure	Time frame	Description
MACCE	Intraoperatively, and within 48 hours.	Death, stroke, and MI

Countries

Russia

Contacts

Primary ContactAndrey A Kaprenko, MD

a_karpenko@meshalkin.ru+79139504100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026