[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605762":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":20,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Acandis GmbH","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Endovascular Treatment Group",null,"This group will be both given medical treatment according to standard clinical routine and treated by carotid artery stenting with the high coverage carotid stent (CARESTO® heal, Acandis® Pforzheim)",{"label":13,"type":10,"description":14,"interventionNames":10},"Best medical treatment group","This group will be given medical treatment according to standard clinical routine",[16],{"name":5,"role":17,"phone":18,"phoneExt":10,"email":19},"CONTACT","+49 (0) 7231 - 155 00 171","info@acandis.com",[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Städtisches Klinikum Solingen","RECRUITING","Solingen","North Rhine-Westphalia","42653","Germany","DE",{"type":30,"coordinates":31},"Point",[32,33],7.0845,51.17343,{"lat":33,"lon":32},[36,39],{"name":37,"role":17,"phone":10,"phoneExt":10,"email":38},"PD Dr. Hannes Nordmeyer","Nordmeyer.Hannes@klinikumsolingen.de",{"name":40,"role":17,"phone":10,"phoneExt":10,"email":41},"Prof. Dr. Marcel Dihné","dihne.marcel@klinikumsolingen.de",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100605762","high-coverage-carotid-stenting-vs-medical-management-alone-to-prevent-embolism-from-symptomatic-non-stenotic-carotid-disease-sync-100605762",false,"NCT07166731","High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)","High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC) - CARESTAR","CARESTAR","Inclusion Criteria:\n\n* Patients diagnosed with acute ischemic stroke or acute retinal artery ischemia within the last two weeks related to symptomatic non-stenotic carotid disease (SyNC) and high-risk carotid plaque features\n\n  * Ipsilateral acute ischemic stroke must be determined by acute ischemic infarct on DWI or CT OR\n  * by neurological symptoms indicating ipsilateral cortical deficits consistent with ischemia in the territory of the internal carotid artery and after exclusion of a significant microangiopathy\n  * Acute retinal artery ischemia must be determined by ophthalmologic examination\n* Patients with no other identifiable cause of stroke, evaluated using standard echocardiographic examinations to exclude cardiogenic or aortogenic sources of embolism\n* Symptomatic non-stenotic carotid disease defined as one or more plaques in the ipsilateral internal carotid artery causing 10-49% luminal narrowing AND\n* Presence of high-risk plaque features which must be determined through visual inspection on CTA or MRI (Ultrasound findings alone are insufficient; features must be confirmed by CTA or MRI to meet the criteria):\n\n  * Identification of at least two of the following characteristics Plaque thickness ≥ 3mm Irregular plaque surface Ulceration \\\u003C50% plaque calcification Lipid-rich necrotic core\n  * and\u002For identification of at least one of the following characteristics Intraplaque haemorrhage\n* Presence of carotid web characterized as shelf-like\u002Flinear, smooth filling defects\n* Plaque assessment including evaluation of the presence of high-risk features by routine imaging (CTA, MRI) confirmed by an independent CoreLab\n* Signed Informed Consent Form\n* Patient ≥ 18 years\n* mRS ≤ 3 at time of randomisation\n* Dual antiplatelet therapy (DAPT) according to standard of care before endovascular treatment\n\nExclusion Criteria:\n\n* Patients with acute complete occlusion of the carotid artery in an emergency setting\n* Incidence of acute infarcts in other vascular (i.e., not ipsilateral carotid) territories\n* Patients in whom the stroke was likely caused by one of the following diseases:\n* Small vessel disease\n\n  * Large vessel atherosclerotic disease ≥ 50%\n  * Cardioembolism\n  * Other known disease e.g. vasculitis\n* Predominantly calcified Plaques (≥50% calcified plaque components on CT-Angio)\n* Patients presenting with intraluminal carotid thrombus (e.g. characterized by 'donut sign' on CTA)\n* Patients with highly tortuous vessels (\\>90°) which may prevent access or safe insertion of the stent\n* Patients with post-CEA re-stenosis or post-CAS re-stenosis\n* Patients with blood coagulation disorders\n* Patients in whom access to the carotid lesion is impossible or associated with an increased risk of procedural complications\n* Patients with lesions in the ostium of the common carotid artery\n* Patients with known hypersensitivity to nickel-titanium\n* Patients who are allergic to heparin\n* Any known conditions that affect life expectancy to less than 12 months\n* Any known conditions associated with an increased risk of endovascular treatment\n* Patients not able to visit the outpatient clinic for annual follow-up","ALL","18 Years",{"count":55,"type":56},536,"ESTIMATED","OBSERVATIONAL","Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.",[60,61,62,63,64,65],"Carotid Artery Disease","Symptomatic Carotid Artery Stenosis","Carotid Artery Stenting","Carotid Plaque Imaging","Embolic Stroke of Undetermined Source","Carotid Artery Thrombosis",[67,68,69,70,71,72],"SyNC","Carotid artery disease","carotid artery stenting","symptomatic non-stenotic carotid artery disease","carotid artery stenosis","symptomatic carotid artery stenosis","2026-03-03",{"date":75,"type":76},"2026-03-04","ACTUAL",{"date":78,"type":76},"2026-03-01",{"date":80,"type":56},"2032-06",{"name":5,"class":6},1]