[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-bifurcation-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-bifurcation-aneurysm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100651102","early-complications-after-flow-diverter-versus-stent-assisted-coiling-for-unruptured-wide-neck-intracranial-bifurcation-aneurysms-100651102",false,"NCT07754188","Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms","Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study","FD-SAC BAS","Inclusion Criteria:\n\n* Voluntarily provides written informed consent.\n* Aged 18 to 75 years.\n* Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.\n* Able to understand the purpose of the study.\n\nExclusion Criteria:\n\n* Patients with two or more multiple aneurysms, all of which require treatment within 1 year.\n* Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.\n* Patients with ruptured aneurysms or narrow-neck aneurysms.\n* Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.\n* Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.\n* Patients who have already planned to undergo surgical or interventional treatment within 3 months.\n* Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.\n* Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.\n* Patients unable to receive antiplatelet or anticoagulant therapy.\n* Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.\n* Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.\n* Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.\n* Pregnant or lactating women.\n* Patients with life expectancy less than 12 months.\n* Patients judged by the investigator to have poor compliance and inability to complete the study as required","ALL","18 Years","75 Years",{"count":21,"type":22},274,"ESTIMATED","30 Days","OBSERVATIONAL","This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.",[27,28,29],"Unruptured Intracranial Aneurysm","Intracranial Bifurcation Aneurysm","Wide-Neck Aneurysm",[31,32,33,34,35,36,37,38,39,40],"Intracranial bifurcation aneurysm","Wide-neck aneurysm","Flow diverter","Stent-assisted coiling","Endovascular treatment","Early complications","Stroke","All-cause mortality","Real-world study","Prospective cohort","RECRUITING","2026-08-04",{"date":44,"type":45},"2026-08-10","ACTUAL",{"date":47,"type":45},"2026-03-19",{"date":49,"type":22},"2028-03-19",{"name":51,"class":52},"Nanfang Hospital, Southern Medical University","OTHER",3]