About this trial
All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient > 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care
Signed informed consent
Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.
De-novo atherosclerotic lesions or neo-atherosclerosis
Disqualifiers
Lack of NeuroVascular Team agreement on carotid revascularization indication
Lack of signed informed consent
Estimated life expectancy less than 1 year
Chronic renal failure with serum creatinine level > 3.0 mg/dL
Trial design
Single group
Treatments tested in this trial
Carotid Artery Stenting
DeviceCarotid artery stenting according to local clinical experience and ESC/ESVS guidelines using exclusively CGuard™, MicroNet covered stent under proximal or distal intraprocedural cerebral protection according to "tailored CAS" algorithm.
Treatment groups
Trial outcomes
Primary outcomes
MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction.
Secondary outcomes
Procedural success
Successful stent delivery and deployment without complication
In-hospital MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction within index hospitalization
30-day MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction within 30 days
Incidence of any periprocedural complications
Any periprocedural complications
Sponsors and contacts
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John Paul II Hospital, Krakow
Lead sponsor
Jagiellonian University
Collaborator