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

Meshalkin Research Institute of Pathology of Circulation

Status: Enrolling

Conditions: Symptomatic Patients (Stenosis > 50%); Patients With Aterosclerotic Carotid Stenosis; Asymptomatic Patients (Stenosis ≥80%)

Treatments: Device: Emboshield NAV6™; Device: Mo.Ma™

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05257161

SIBERIA 2

Details and patient eligibility

About

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.

Enrollment: 366 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Device: Emboshield NAV6™

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

Experimental group

Description:

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

Treatment:

Device: Mo.Ma™