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Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)

Recruitingn/aAges 18 Years - anyAllJohn Paul II Hospital, Krakow
NCT05195658 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use. A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management. A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis/occlusion as culprit lesion. * Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs. * Patient eligible for endovascular stroke therapy according to AHA/ASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice. * Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center) * Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated. Exclusion Criteria: * Known stroke cause other than the carotid bifurcation lesion * Lack of effective endovascular route needed for intervention * Any known contraindications to stroke endovascular management
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What it tests

  • Thrombectomy and Stenting under neuroprotection
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Where

1 site
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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