Comparing two methods of carotid artery stenting for better neurological outcomes

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 366 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Meshalkin Research Institute of Pathology of Circulation (network)
• Locations: 1 site (Novosibirsk)
• Trial ID: NCT05257161 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45-80 with symptomatic or asymptomatic carotid stenosis who meet specific health criteria.

Not a fit: Patients with recent strokes, myocardial infarctions, or significant hepatic or renal diseases may not benefit from this study.

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 performed: Previous studies have shown advantages of the CGuard stent, but the comparison of distal versus proximal protection devices is less established.

Eligibility 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 this trial is running

Novosibirsk

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

Study contacts

• Study coordinator: Andrey A Kaprenko, MD

Conditions: Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients, Asymptomatic Patients, Carotid artery stenting. CGuard stent. Protection Device.