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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05257161

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

366

Starts

2021-11-01

Expected to finish

2027-01-01

Last updated by the study team

2022-02-25

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• E. Meshalkin National Medical Research Center — Novosibirsk, Russia (enrolling)

Full record on ClinicalTrials.gov

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