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RecruitingNot ApplicableNCT05257161

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

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Enrollment

366 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 45 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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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™

Locations(1)

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

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NCT05257161