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

NCT05257161 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-02-25

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Emboshield NAV6™

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

DEVICE

Mo.Ma™

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

Sponsors & Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    collaborator OTHER

  • Chelyabinsk Regional Clinical Hospital

    collaborator OTHER_GOV

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-11-01
Completion
2027-01-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257161 on ClinicalTrials.gov