[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619033":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":11,"locations":25,"responsibleParty":37,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":11,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":11,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":11,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"World Medica USA, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"World Diverter Implantation","EXPERIMENTAL",null,[13],"Device: Flow diverter implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Flow diverter implantation","Implantation of the World Diverter Embolization Device",[9],[21],{"name":22,"affiliation":23,"role":24},"Alejandro Tomasello, MD","Hospital Vall d'Hebron","PRINCIPAL_INVESTIGATOR",[26],{"facility":27,"status":11,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"Hospital Universitari Vall d'Hebron","Barcelona","Spain","ES",{"type":32,"coordinates":33},"Point",[34,35],2.15899,41.38879,{"lat":35,"lon":34},{"type":38,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619033","safety--performance-of-the-world-medica-world-diverter-embolization-device-100619033",false,"NCT07339358","Safety & Performance of the World Medica World Diverter Embolization Device","Inclusion Criteria:\n\n* Age 18 22 to 80 years\n* Subject, or subject's legal representative provided informed consent\n* Subject agrees to the requirements of the study, including returning for required follow-up visits\n* Parent artery diameter of 2.0-5.5 mm distal and proximal to the target IA\n* Subject has a single target IA in the index procedure with the following characteristics: (1) Unruptured; (2) Located in the ICA from the petrous through the superior hypophyseal segments; and (3) Is a fusiform or saccular wide-necked IA with one of the following characteristics: (a) Small (\\\u003C 5 mm) or medium (\\>5-10 mm) size with a neck width ≥ 4.0 mm or a dome-to-neck ratio of \\\u003C 2; OR (b) Large (\\>10-25 mm) or giant (\\>25 mm) size\n\nExclusion Criteria:\n\n* A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure\n* A bleeding disorder or a platelet count of less than 100x103\u002Fmm3 or INR \\>1.5\n* A contraindication to or inability to tolerate antiplatelet therapy\n* An allergy to radiographic contrast agents\n* An allergy to  nickel, titanium, platinum, tungsten, or stainless steel\n* An allergy to local or general anesthesia\n* A history of untreated atrial fibrillation, untreated\u002Funcontrollable hypertension, or other stroke risk factors\n* A history of deep vein thrombosis or pulmonary embolism\n* A history of heart failure, dilated cardiomyopathy, or congenital heart conditions\n* Hypercoagulopathy or a hemorrhagic or coagulation deficiency refractory to medical therapy or subject refuses treatment with blood products\n* Suffered a stroke within 180 days preceding the index procedure\n* Had major surgery within the 30 days preceding or planned for the 180 days following the index procedure, including but not limited to intracranial stenting or coiling\n* Target aneurysm has been previously treated with clipping, coiling, or flow diversion\n* Had previous stenting of or implant in parent artery proximal to the target aneurysm that could interfere with delivery or performance of study device\n* Asymptomatic extradural aneurysms requiring treatment\n* Contraindication to computed tomography (CT) or magnetic resonance (MR)\n* An unstable neurological deficit (i.e., worsening of a clinical condition within the 30 days preceding the index procedure)\n* Evidence of an active systemic infection (including COVID-19) at index procedure\n* Dementia or other cognitive condition limiting their ability to participate in the study\n* A condition that may limit survival to less than 12 months post-index procedure\n* Serum creatinine ≥2.5 mg\u002FdL\n* Had radiation or chemotherapy treatment either currently or within the 60 days preceding the index procedure\n* Current enrollment in a separate clinical trial\n* Another condition(s) that, in the opinion of the Investigator, could interfere with the ability to perform a safe or effective procedure\n* Current pregnancy or plan to become pregnant within the 12 months following the index procedure, or be currently breastfeeding\n\nAngiographic Exclusion Criteria:\n\n* Anatomy not amenable to endovascular treatment, including but not limited to severe vessel tortuosity or stenosis\n* Parent vessel stenosis is \\>50% in the target area\n* Extracranial stenosis of the carotid artery \\>50%\n* An intracranial mass\n* More than one vessel segment requiring IA treatment in the 12 months following the index procedure\n* Target aneurysm is mycotic or dissecting\n* Target aneurysm is at bifurcation\n* Target aneurysm will require coiling in addition to flow diversion, in Investigator's opinion","ALL","22 Years","80 Years",{"count":49,"type":50},72,"ESTIMATED","INTERVENTIONAL",[53],"NA","The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \\\u003C2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.",[56],"Intracranial Aneurysm","NOT_YET_RECRUITING","2026-01-13",{"date":60,"type":61},"2026-01-14","ACTUAL",{"date":63,"type":50},"2026-03-31",{"date":65,"type":50},"2028-08-31",{"name":5,"class":6},1]