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

Not Applicable

Recruiting

• Conditions: Symptomatic Patients (Stenosis > 50%); Asymptomatic Patients (Stenosis ≥80%); Patients With Aterosclerotic Carotid Stenosis
• Interventions: Device: Mo.Ma™; Device: Emboshield NAV6™

• Registration Number: NCT05257161
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25
• Primary Completion: 2026-11-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)	Mo.Ma™	183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS))
Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))	Emboshield NAV6™	183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS))

Primary Outcome Measures

Name	Time	Method
determination of ischemic lesions	24-48 hours	Postprocedural acute ischemic lesions (MRI)

Secondary Outcome Measures

Name	Time	Method
MACCE	Intraoperatively, and within 48 hours.	Death, stroke, and MI

Trial Locations

Locations (1)

E. Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation