Comparing two methods of carotid artery stenting for better neurological outcomes
Official title: Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
Run by Meshalkin Research Institute of Pathology of Circulation · NCT05257161 · Data updated 2026-11-12
This study is testing whether using a specific type of stent with different protective devices can lead to better brain health outcomes for patients with narrowed carotid arteries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 80 Years |
| Sex | All |
| Enrollment | 366 (estimated) |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation Research network |
| Locations | 1 site (Novosibirsk) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | November 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | February 25, 2022 |
| Trial ID | NCT05257161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 45-80 with symptomatic or asymptomatic carotid stenosis who meet specific health criteria.
✕Probably not a fit
Patients with recent strokes, myocardial infarctions, or significant hepatic or renal diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of the CGuard stent in patients with atherosclerotic carotid stenosis, focusing on early neurological outcomes when using either a distal or proximal anti-embolic protection device. The study aims to determine if there is a significant difference in outcomes between these two approaches. Eligible participants include symptomatic and asymptomatic patients with varying degrees of stenosis, who will undergo carotid artery stenting. The trial will assess the safety and efficacy of the interventions through follow-up procedures and imaging.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological outcomes for patients undergoing carotid artery stenting.
How similar studies have gone: Previous studies have shown advantages of the CGuard stent, but the comparison of distal versus proximal protection devices is less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice. 2. More than 6-month life expectancy 3. Suitable clinical conditions for performing DW-MRI 4. Written Informed consent approved by the Ethics Committee 5. Subject agrees to all required follow-up procedures and visits 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
Where it's running
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E. Meshalkin National Medical Research Center
Novosibirsk, Russia Recruiting
Study contacts
- Study coordinator: Andrey A Kaprenko, MD
- Email: a_karpenko@meshalkin.ru
- Phone: +79139504100
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.