[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575082":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":58,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Italian Society of Vascular and Endovascular Surgery","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A : Within 72 hours of the ischemic symptom","EXPERIMENTAL","The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes:\n\nGROUP A : Within 72 hours of the ischemic symptom. GROUP B: Between 72 hours and 14 days after the symptom.\n\nThe two study groups will not differ in the type of treatment offered but only in the timing of its execution.\n\nNo experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.",[13],"Procedure: CEA (carotid endarterectomy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Between 72 hours and 14 days after the ischemic symptom","ACTIVE_COMPARATOR","see above",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","CEA (carotid endarterectomy)","Intervention (CEA) is associated to both arms (group A and B)",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"EMILIANO CHISCI, MD","CONTACT","+39 3281970637","e.chisci@gmail.com",[33,49],{"facility":34,"status":35,"city":36,"state":25,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Usl Toscana Centro","NOT_YET_RECRUITING","Florence","50143","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],11.24626,43.77925,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":30,"phoneExt":25,"email":31},"Emiliano Chisci, MD",{"facility":34,"status":50,"city":36,"state":25,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"RECRUITING",{"type":41,"coordinates":52},[43,44],{"lat":44,"lon":43},[55],{"name":56,"role":29,"phone":30,"phoneExt":25,"email":57},"emiliano chisci","emiliano.chisci@ulscentro.toscana.it",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","EMILIANO CHISCI","Principal Investigator, Head of Endovascular Aortic UNIT, San Giovanni di Dio Hospital, USL Toscana Centro, Florence, ITALY","100575082","urgent-carotid-endarterectomy-cea-versus-delayed-cea-in-symptomatic-carotid-stenosis-spread-staci-ii-100575082",false,"NCT06767657","Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)","Multicenter, Open-label Randomized Study Comparing Urgent Carotid Endarterectomy (CEA) (Within 72 Hours) Versus Delayed CEA (After 72 Hours) in Patients With Symptomatic Carotid Stenosis (SPREAD-STACI II)","Time_to_sCEA","Eligibility Criteria\n\nInclusion Criteria:\n\nPatients presenting with the following characteristics:\n\nDe novo stenosis of the carotid bifurcation and\u002For internal carotid artery origin, equal to or greater than 50% (NASCET method), diagnosed by color Doppler ultrasound, MR angiography (MRA), CT angiography (CTA), or catheter angiography.\n\nTIA or minor ischemic stroke (NIHSS ≤ 5) ipsilateral to the carotid stenosis, occurring within the previous 24 hours.\n\nPreserved consciousness and neurologically stable symptoms. No evidence of ongoing cerebral ischemia, or evidence of cerebral ischemia with a diameter \\\u003C25 mm.\n\nAge between 45 and 90 years. ASA score \\\u003C 4. Ability to comply with follow-up requirements as specified. Willingness to provide informed consent for participation in the study.\n\nA patient with an NIHSS ≤ 5 who is aphasic may be unable to provide consent. In these cases:\n\nThe attending physician assesses the feasibility of including the patient. Family members are informed but, under Italian law, cannot provide consent. A third-party physician certifies that the patient meets the inclusion criteria.\n\nThe attending physician signs the appropriate form, and randomization proceeds. If and when the patient regains the ability to provide or refuse consent, the informed consent form will be presented to them. Should they decline, their data will be removed from the study database.\n\nAdditionally, the study includes patients who underwent thrombolysis and\u002For mechanical thrombectomy after the onset of the index symptom, followed by a brain CT\u002FMRI without secondary cerebral hemorrhage (PH1, PH2, or PHr).\n\nExclusion Criteria:\n\nStenosis \\\u003C 50% (NASCET method) at the bifurcation and\u002For internal carotid artery origin, diagnosed by ECD, CTA, or MRA.\n\nCarotid thrombosis or dissection. NIHSS \\> 5. Cerebral hemorrhage. Impaired consciousness or neurologically unstable condition. Cancer, any condition with a poor prognosis, major cardiopathy, or any severe neurological disorder.\n\nCT or MRI evidence of cerebral ischemia \\> 25 mm in diameter. CT or MRI evidence of cerebral lesions of uncertain origin. Recurrent TIA or stroke-in-evolution. Age \\\u003C 45 years or \\> 90 years. ASA risk score = 4. Lack of informed consent. Inability to undergo CEA within 72 hours of the initial ischemic symptom. Inability to participate in a 90-day follow-up after the initial ischemic symptom.\n\nPrevious CEA or stenting of the examined carotid artery.","ALL","45 Years","90 Years",{"count":74,"type":75},456,"ESTIMATED","INTERVENTIONAL",[78],"NA","In patients with internal carotid artery (ICA) stenosis of 50% or greater (measured according to the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)) who have experienced a transient ischemic attack (TIA) or minor ipsilateral stroke, carotid endarterectomy (CEA) offers maximum benefit if performed within 15 days of the initial ischemic symptom. National and international guidelines recommend surgical treatment (CEA) within this timeframe; however, no studies have specifically evaluated the optimal timing for CEA after a TIA or minor stroke.\n\nIt is well established that the risk of a major stroke is highest in the first few days following a transient ischemic attack or minor stroke and then decreases over the subsequent days and weeks.\n\nThis raises the hypothesis that performing an urgent carotid endarterectomy (within 3 days) may provide greater benefit compared to a delayed procedure (between 4 and 15 days).",[81,82,83,84],"Stroke, Ischemic","Transient Ischemic Accident","Endarterectomy, Carotid","Stroke Prevention",[86,87,88,89],"stroke","endarterectomy","transient ischemic accident","stroke prevention","2026-03-02",{"date":92,"type":93},"2026-03-04","ACTUAL",{"date":95,"type":93},"2025-07-03",{"date":97,"type":75},"2028-01-01",{"name":5,"class":6},2]