[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454293":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"John Paul II Hospital, Krakow","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute ischemic stroke with culprit lesion at the carotid bifurcation",null,"Consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, accepted for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines",[13],"Device: Thrombectomy and Stenting under neuroprotection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Thrombectomy and Stenting under neuroprotection","Endovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection.\n\nTransient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration\u002Fs at key procedural steps. If indicated, targeted (extra- and\u002For intracranial) thrombus retrieval using either a thrombus aspiration device and\u002For a stentriever.\n\nUse of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center.\n\nPatient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA\u002FASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center.",[9],[21],{"name":22,"affiliation":23,"role":24},"Piotr Musialek, MD, DPhil","Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+48126142287","pmusialek@szpitaljp2.krakow.pl",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Lukasz Tekieli, MD, PhD","+48126143501","luk.tekieli@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Cardiac and Vascular Diseases, John Paul II Hospital","RECRUITING","Krakow","31-202","Poland","PL",{"type":43,"coordinates":44},"Point",[45,46],19.93658,50.06143,{"lat":46,"lon":45},[49],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100454293","acute-stroke-of-carotid-artery-bifurcation-origin-treated-with-use-of-the-micronet-covered-cguard-safeguard-stroke-100454293",false,"NCT05195658","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study","Inclusion Criteria:\n\n* Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis\u002Focclusion as culprit lesion.\n* Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.\n* Patient eligible for endovascular stroke therapy according to AHA\u002FASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.\n* 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)\n* 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.\n\nExclusion Criteria:\n\n* Known stroke cause other than the carotid bifurcation lesion\n* Lack of effective endovascular route needed for intervention\n* Any known contraindications to stroke endovascular management","ALL","18 Years",{"count":62,"type":63},20,"ESTIMATED","OBSERVATIONAL","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.\n\nA 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\u002For cerebral tissue window allowing guideline-indicated reperfusion by interventional management.\n\nA 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.",[67,68],"Carotid Artery Stenosis","Acute Ischemic Stroke",[70,68,71,72,73,74],"Carotid Stenosis","Anesthesia","Imaging","Interventional Management","Thrombectomy","2022-02-23",{"date":77,"type":78},"2022-02-28","ACTUAL",{"date":80,"type":78},"2022-01-30",{"date":82,"type":63},"2027-12-31",{"name":5,"class":6},1]