[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647326":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":57,"collaborators":59,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stent Assisted Coiling Group","ACTIVE_COMPARATOR","Traditional Group (Stent Assisted Coiling):\n\nThe patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a",[13],"Device: Stent Assisted Coiling Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Flow Diverter Group","EXPERIMENTAL","Flow Diverter Group:\n\nThe patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane",[19],"Device: Flow Diverter Group",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Flow diversion with the Pipeline™ (Flex\u002FShield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Huibin Kang, MD","CONTACT","+8602062787842","kanghuibindoctor@163.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Wenfeng Feng, MD","+8602062787665","fengwf1967@163.com",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Guangzhou","Guangdong","510515","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54,56],{"name":31,"role":32,"phone":55,"phoneExt":25,"email":34},"13520296286",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60,62,64,66,68,70,72,74,77,79,81,83],{"name":61,"class":6},"Shenzhen Second People's Hospital",{"name":63,"class":6},"Guangdong Provincial People's Hospital",{"name":65,"class":6},"Liv Hospital Ankara",{"name":67,"class":6},"ZhuHai Hospital",{"name":69,"class":6},"West China Hospital",{"name":71,"class":6},"Beijing Tiantan Hospital",{"name":73,"class":6},"Henan Provincial People's Hospital",{"name":75,"class":76},"Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China","UNKNOWN",{"name":78,"class":76},"Guangdong Second Provincial People's Hospital",{"name":80,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":82,"class":6},"Xuanwu Hospital, Beijing",{"name":84,"class":76},"Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand","100647326","flow-diverter-versus-conventional-endovascular-treatment-for-unruptured-wide-neck-bifurcation-aneurysms-fd-bwa-trial-100647326",false,"NCT07707076","Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)","Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)","FD-BWA","Inclusion Criteria:\n\n1. Age 18-75 years;\n2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA\u002FCTA\u002FMRA;\n3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with two or more multiple aneurysms that all require treatment within 1 year;\n2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;\n3. Ruptured aneurysms and narrow-neck aneurysms;\n4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;\n5. Extremely poor clinical condition, modified Rankin Score ≥3;\n6. Patients already scheduled for surgery\u002Finterventional procedure within 3 months;\n7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);\n8. Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness;\n9. Patients unable to receive antiplatelet or anticoagulant therapy;\n10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;\n11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;\n12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;\n13. Pregnant or breastfeeding women;\n14. Patient's life expectancy less than 12 months;\n15. Investigator judges that the patient has poor compliance and cannot complete the study as required.","ALL","18 Years","75 Years",{"count":97,"type":98},266,"ESTIMATED","INTERVENTIONAL",[101],"NA","Brief Summary：\n\nThe goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are:\n\n* Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter?\n* What medical problems do participants experience during and after each treatment?\n* What are the imaging cure and stability rates at 1, 2, and 5 years after treatment?\n\nResearchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes.\n\nParticipants will:\n\n* Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling\n* Undergo the assigned endovascular procedure\n* Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)",[104],"Unruptured Intracranial Wide-neck Bifurcation Aneurysms",[106,107,108,109,110],"intracranial aneurysms","wide-neck","bifurcation","flow diverter","unruptured","2026-07-10",{"date":113,"type":114},"2026-07-16","ACTUAL",{"date":116,"type":114},"2026-02-10",{"date":118,"type":98},"2030-06-30",{"name":5,"class":6},1]