Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting.
Piero Montorsi, Luigi Caputi, Stefano Galli...
https://pubmed.ncbi.nlm.nih.gov/32007460Actively Recruiting
Phase Not Applicable
Age: 45Years - 80Years
All Genders
ID05257161
Independent Randomized Clinical Trial Comparing Early Neurological Outcomes of Distal Versus Proximal Embolic Protection Devices Using the CGuard MicroNet Covered Stent in Carotid Revascularization
Led by Meshalkin Research Institute of Pathology of Circulation · Updated on 2022-02-25
366
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Meshalkin Research Institute of Pathology of Circulation
Lead Sponsor
F
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with atherosclerotic carotid stenosis, including both symptomatic patients with stenosis over 50% and asymptomatic patients with stenosis 80% or greater. This trial compares early neurological outcomes using two different embolic protection devices combined with the CGuard microNet covered stent. The purpose is to evaluate whether distal or proximal embolic protection device placement offers better results, expanding on previous findings that showed CGuard stent implantation had advantages over classical stents using distal protection. Participants will undergo carotid artery stenting with one of two devices: the Emboshield NAV6 distal embolic protection system plus the CGuard stent, or the Mo.Ma proximal cerebral protection device plus the CGuard stent. The study groups are randomized and unblinded, and both devices aim to reduce embolic events during the stenting procedure. The trial began in November 2021 and will continue until January 2027. During the study, participants will receive neurological assessments and brain imaging to detect ischemic lesions within 24 to 48 hours after the procedure. The primary outcome is the determination of these ischemic lesions, while secondary outcomes include monitoring major adverse cardiac and cerebrovascular events during and shortly after the procedure. Participants must consent to follow-up visits and procedures as part of the trial involvement.
CONDITIONS
Brief Title
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Who Can Participate
Age: 45Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Consecutive patients aged 45 to 80 years accepted for carotid artery stenting after neurological consultation
- Life expectancy greater than 6 months
- Suitable clinical condition for diffusion-weighted MRI
- Written informed consent approved by the Ethics Committee
- Agreement to all required follow-up procedures and visits
You will not qualify if you...
- Currently enrolled in another investigational device or drug study that is incomplete or interferes with this study
- Recent surgery within 30 days before or planned surgery within 30 days after the stenting procedure
- Active liver disease with bilirubin over 35 mmol/L or kidney insufficiency (creatinine over 2.5 mg/dL or glomerular filtration rate under 60 ml/min)
- Recent evolving acute stroke within 30 days before evaluation
- Myocardial infarction within 72 hours before stenting (CPK-MB over 3 times normal)
- Female patients of childbearing potential or known pregnancy
- Known risk factors for stroke other than carotid stenosis, such as atrial fibrillation, atrial flutter, or thrombophilia
- Current treatment with vitamin K antagonists or new oral anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure day
Participants undergo carotid artery stenting using either the distal Emboshield NAV6™ or the proximal MO.MA embolic protection device combined with the CGuard™ stent.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 48 hours
Participants are monitored for early neurological outcomes and safety within 48 hours after the procedure.
1 to 2 visits (in-person) within 48 hours post-procedure
Trial Site Locations
Total: 1 location
1
E. Meshalkin National Medical Research Center
Novosibirsk, Russia
Actively Recruiting
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Research Team
A
Andrey A Kaprenko, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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