[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640568":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":47,"overallOfficials":11,"centralContacts":57,"locations":11,"responsibleParty":66,"collaborators":11,"id":68,"slug":11,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":11},{"fullName":5,"class":6},"Instituto de Investigación Marqués de Valdecilla","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting",null,"Within 48 hours after the procedure",[14,17,20,23],{"measure":15,"description":11,"timeFrame":16},"Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days","During the procedure and within 30 days after the intervention",{"measure":18,"description":11,"timeFrame":19},"Incidence of myocardial infarction or death within 30 days","30days",{"measure":21,"description":22,"timeFrame":19},"Technical success of carotid artery stenting procedure","Technical success defined as successful deployment of the stent with residual stenosis \\\u003C30% and restoration of adequate blood flow without the need for conversion to another technique.",{"measure":24,"description":11,"timeFrame":25},"Correlation between DW-MRI findings and clinical outcomes","30 days",{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants are randomly assigned in a 1:1 ratio to carotid artery stenting with or without proximal embolic protection using a balloon guide catheter.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"SINGLE","Outcome assessors (neurologists and radiologists evaluating diffusion-weighted MRI images) are blinded to treatment allocation. Participants and interventional staff are not blinded due to the nature of the procedure.",[35],"OUTCOMES_ASSESSOR",[37,42],{"label":38,"type":39,"description":11,"interventionNames":40},"carotid artery stenting with proximal embolic protection using a balloon guide catheter","EXPERIMENTAL",[41],"Device: balloon guide catheter",{"label":43,"type":44,"description":11,"interventionNames":45},"ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter.","ACTIVE_COMPARATOR",[46],"Other: No Proximal Protection Group",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"DEVICE","balloon guide catheter","Carotid artery stenting with proximal embolic protection using a balloon guide catheter.",[38],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"No Proximal Protection Group","Carotid artery stenting without proximal embolic protection",[43],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":11,"email":62},"veronica vidal","CONTACT","942203389","veronica.vidal@idival.org",{"name":64,"role":60,"phone":11,"phoneExt":11,"email":65},"lucia lavin","lucia.lavin@idival.org",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640568",false,"NCT07576790","Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)","Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)","EMBO-PROTECT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptomatic or asymptomatic carotid artery stenosis\n* Candidate for carotid artery stenting\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Vascular anatomy unsuitable for balloon guide catheter placement\n* Severe renal failure\n* Previous disabling stroke or symptomatic intracranial hemorrhage\n* Evidence of carotid thrombus\n* Severe common carotid artery lesion\n* Chronic atrial fibrillation on oral anticoagulation\n* Acute coronary syndrome within 30 days\n* Contraindications to anticoagulant or antiplatelet therapy\n* Contraindications to MRI\n* Contrast media allergy\n* Lack of prior dual antiplatelet therapy","ALL","18 Years",{"count":78,"type":79},126,"ESTIMATED","INTERVENTIONAL",[82],"NA","Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.",[85],"Carotid Artery Stenosis (Symptomatic and Asymptomatic)",[87,88,89,90,91,92,93],"Carotid stenosis","Carotid artery stenting","Balloon guide catheter","Proximal embolic protection","Cerebral microembolism","Diffusion-weighted MRI","Stroke prevention","NOT_YET_RECRUITING","2026-05-04",{"date":97,"type":98},"2026-05-08","ACTUAL",{"date":100,"type":79},"2026-07-01",{"date":102,"type":79},"2027-12-31",{"name":5,"class":6}]