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Recruiting NCT04271033

MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

Trial Parameters

Condition Carotid Artery Diseases
Sponsor John Paul II Hospital, Krakow
Study Type INTERVENTIONAL
Phase N/A
Enrollment 550
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2015-09-01
Completion 2022-06
Interventions
Carotid Artery Stenting

Brief Summary

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

General Inclusion Criteria: * 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. Angiographic Inclusion Criteria: * De-novo atherosclerotic lesions or neo-atherosclerosis * Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or * Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method General Exclusion Criteria: * 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 * Myocardial Infarction within 72 hours prior to index procedure. * Pregn

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