Menu
Recruiting NCT05257161

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

No phase Interventional Patients With Aterosclerotic Carotid Stenosis Symptomatic Patients (Stenosis > 50%) Asymptomatic Patients (Stenosis ≥80%)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emboshield NAV6™, Mo.Ma™.
Who it may be relevant to
Registry conditions: Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%). Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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™

Primary outcome measures

  • determination of ischemic lesions [Time frame: 24-48 hours]
Secondary outcome measures (1)
  • MACCE [Time frame: Intraoperatively, and within 48 hours.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • E. Meshalkin National Medical Research Center — Novosibirsk

Publications

  • 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/ PMID 32007460

Identifiers

NCT: NCT05257161 · SIBERIA 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗