[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"flow-diverter\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:flow-diverter":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,72,99,128],{"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":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644750","surface-modified-flow-diverter-for-intracranial-aneurysms-assessment-of-ischemic-and-clinical-outcomes-100644750",false,"NCT07674004","Surface-Modified Flow Diverter for Intracranial Aneurysms: Assessment of Ischemic and Clinical Outcomes","Prospective Randomized Controlled Trial of Surface-Modified Flow Diverter for Intracranial Aneurysms: Multicenter Assessment of Ischemic and Clinical Outcomes","PRISMATIC","Inclusion Criteria:\n\n1. Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield\u002FLattice).\n2. During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices.\n3. The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.\n4. The age of enrolled patients ranged from 18 to 75 years old.\n5. Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes.\n\nExclusion Criteria:\n\n1. Patients with a prior history of endovascular treatment for the target aneurysm.\n2. Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).\n3. Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.\n4. Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation).\n5. Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.\n6. Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU).\n7. Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study.\n8. Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits.\n9. Pregnant or lactating female patients.","ALL","18 Years","75 Years",{"count":21,"type":22},196,"ESTIMATED","INTERVENTIONAL",[25],"NA","Flow diverters (FDs) have become a mainstay of endovascular therapy for unruptured intracranial aneurysms (UIAs), yet their implantation carries an inherent risk of ischemic complications. The Pipeline Flex Embolization Device with Shield Technology (PED Shield) and the Lattice Flow Diverter (LFD) are two surface-modified FDs that have shown promising efficacy for mitigating procedure-related ischemic events in prior single-arm or retrospective series. Nevertheless, head-to-head comparative data between these two surface-modified flow diverters remain scarce, and prospective randomized clinical trials are warranted to corroborate their differential performance in lowering ischemic complication risks.This prospective, multicenter randomized controlled trial (RCT) was designed to compare the efficacy of PED Shield versus LFD in reducing ischemic complications after endovascular treatment of UIAs. A total of 196 eligible participants who meet the predefined inclusion and exclusion criteria will be enrolled in the trial. The primary outcome measure is the incidence of new diffusion-weighted imaging (DWI)-positive lesions on brain magnetic resonance imaging (MRI) within 48 hours after the procedure. The secondary outcome measures consist of perioperative symptomatic ischemic events, all-cause mortality and disability rate during the follow-up period, delayed aneurysm rupture at the 6-month follow-up, complete aneurysm occlusion rate, incidence of major in-stent stenosis (stenosis degree \\>50%) at the 6-month follow-up, and the number of new DWI-positive lesions within 48 hours post-procedure.",[28,29],"Intracranial Aneurysms","Flow Diverter",[31,32,33],"intracranial aneurysms","flow dierters","surface-modified","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2026-05-21",{"date":42,"type":22},"2027-09-30",{"name":44,"class":45},"Henan Provincial People's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100621591","phase-4-flow-diverting-devices-for-the-treatment-of-middle-cerebral-artery-bifurcation-aneurysms-100621591","NCT07372612","Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms","A Prospective Randomized Controlled Trial of Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms","Inclusion Criteria:\n\n1. Unruptured wide-necked middle cerebral artery bifurcation aneurysms definitively diagnosed by CTA or DSA;\n2. Aneurysms requiring stent-assisted embolization with the necessity of preserving branch arteries;\n3. Indication for either flow diversion device or conventional stent-assisted coiling;\n4. Age between 18 and 70 years, inclusive;\n5. The subject or their legally authorized representative has signed the written informed consent form.\n\nExclusion Criteria:\n\n1. Concomitant significant organ dysfunction (e.g., severe cardiac, hepatic, or renal insufficiency), chronic inflammatory disease, or malignancy;\n2. Pregnant or lactating women;\n3. Presence of significant neurological deficit (mRS score \\> 2);\n4. Presence of contraindications to flow diversion device or stent-assisted coiling (e.g., severe allergy to metallic material, contraindication to antiplatelet medication);\n5. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":55,"type":22},140,[57],"PHASE4","The goal of this clinical trial is to learn if flow diverter (FD) offers advantages over conventional stent-assisted coiling in the treatment of middle cerebral artery (MCA) bifurcation aneurysms . It will also learn about the safety of flow diverter (FD) treatment. The main questions it aims to answer are:\n\nDoes flow diverter (FD) treatment improves the rate of complete aneurysm occlusion and patients' neurological function? Does flow diverter (FD) treatment loweres the probability of aneurysm recurrence and the occurrence of complications?\n\nResearchers will compare FD to a conventional stent-assisted coiling to see if FD treatment works better to treat MCA bifurcation aneurysms.\n\nParticipants will:\n\nUndergo stent-assisted coiling or flow diverter treatment Take pre-operative and pre-discharge head MRI scans, neurological function assessments, and cognitive function assessments Visit the clinic 1 year for checkups and tests",[60,29,61,62],"Aneurysms","Middle Cerebral Artery Aneurysm","Coiling Therapy","NOT_YET_RECRUITING","2026-01-20",{"date":66,"type":38},"2026-01-28",{"date":64,"type":22},{"date":69,"type":22},"2028-10-15",{"name":71,"class":45},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100620140","phase-4-efficacy-and-safety-of-methylprednisolone-after-flow-diverter-stent-implantation-in-unruptured-intracranial-aneurysms-100620140","NCT07353749","Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms","Efficacy and Safety of Methylprednisolone in Preventing Adverse Cerebrovascular Events After Flow-Diverter Stent Implantation in Patients With Unruptured Intracranial Aneurysms: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* （1）Aged ≥ 18 years; （2）Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA;\n\n  （3）IA size ranging from 3 to 25 mm;\n\n  （4）The patient and\u002For their authorized representative can understand the study purpose, voluntarily participate, and sign the informed consent form;\n\n  （5）Patients scheduled to receive flow diverter treatment;\n\n  （6）Patients willing to complete follow-up evaluations in accordance with the clinical study protocol.\n\nExclusion Criteria:\n\n* （1）Patients with two or more multiple aneurysms who require secondary treatment within one month; （2）Female patients who are planning to become pregnant, are pregnant, or are breastfeeding;\n\n  （3）Pre-onset modified Rankin Scale (mRS) score ≥ 2;\n\n  （4）Patients complicated with systemic infectious diseases (latent or active stage), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, or ocular herpes simplex; patients with contraindications to glucocorticoids, such as active peptic ulcer and severe fungal infection;\n\n  （5）Ruptured aneurysms, recurrent aneurysms, infectious aneurysms, dissecting aneurysms; complicated with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc.;\n\n  （6）Patients with symptomatic cerebrovascular stenosis ≥ 70%;\n\n  （7）Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 30 days;\n\n  （8）Patients scheduled to undergo other surgical\u002Finterventional procedures within 30 days;\n\n  （9）Patients with severe comorbidities unsuitable for anesthesia or surgical treatment, such as major diseases of the heart, lungs, liver, spleen, and kidneys, atrial fibrillation, brain tumors, severe active infections, disseminated intravascular coagulation, and severe psychiatric history;\n\n  （10）Patients who cannot receive antiplatelet aggregation or anticoagulant therapy;\n\n  （11）Hypersensitivity to methylprednisolone sodium succinate;\n\n  （12）Patients receiving long-term hormone therapy (≥ 1 week) due to other comorbidities before surgery;\n\n  （13）Patients taking hepatic enzyme-inducing drugs, such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and aminoglutethimide; or patients taking hepatic enzyme-inhibiting drugs, such as erythromycin and ketoconazole;\n\n  （14）Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate \\\u003C 30 ml\u002Fmin or serum creatinine \\> 220 μmol\u002FL (2.5 mg\u002Fdl));\n\n  （15）Systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg that is uncontrollable with oral antihypertensive drugs;\n\n  （16）Blood glucose \\\u003C 2.8 mmol\u002FL or \\> 22.2 mmol\u002FL;\n\n  （17）Patients who have received a vaccine injection within the past month or have a plan for vaccination;\n\n  （18）Patients who cannot understand or are unwilling to complete follow-up evaluations in accordance with the clinical study protocol;\n\n  （19）Patients with advanced diseases with an expected life expectancy of \\\u003C 6 months;\n\n  （20）Patients currently participating in other clinical trials.",{"count":80,"type":22},864,[57],"Study Title: Testing Methylprednisolone to Prevent Strokes After a Stent Procedure for Brain Aneurysms\n\nWhat is the purpose of this study? This study aims to find out if a short course of a steroid medicine called methylprednisolone can help prevent strokes and other brain-related complications in patients who have a \"flow diverter\" stent placed to treat an unruptured brain aneurysm. The main goal is to see if this treatment reduces the combined number of new strokes (both clot-related and bleeding-related) or brain injury-related deaths within the first 30 days after the procedure.\n\nWho can participate? Adults aged 18 or older with an unruptured brain aneurysm (size 3-25mm) who are scheduled to receive a flow-diverting stent and can provide informed consent may be eligible. Key reasons someone might not be able to join include: having multiple aneurysms needing quick treatment, being pregnant or breastfeeding, having a history of recent stroke, having active infections or stomach ulcers, having severe kidney disease, having very high\u002Funcontrolled blood pressure or blood sugar, or already being on long-term steroid therapy.\n\nWhat will happen in the study?\n\nThis is a multicenter, randomized, double-blind study. This means:\n\nParticipants will be randomly assigned (like flipping a coin) to one of two groups.\n\nOne group will receive methylprednisolone. The other group will receive a placebo (an inactive substance that looks identical).\n\nNeither the participants nor their doctors will know which treatment is being given.\n\nAll participants will receive the standard care for the stent procedure and aftercare.\n\nHow long will the study last? The treatment period is short (around the time of the procedure). Participants will be closely monitored in the hospital and will have a follow-up visit around 30 days after the procedure to check their health status.\n\nWhat will be measured? The researchers will mainly track whether participants have any stroke or brain injury-related death in the first 30 days. They will also check for other complications like bleeding, infections, and changes in daily function and quality of life. Safety will be monitored throughout.\n\nHow many people will take part? The study plans to enroll approximately 864 participants across multiple hospitals.\n\nStudy Dates:\n\nThe study is expected to start enrolling patients in January 2026 and finish in August 2027.\n\nWho is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.",[84,85,86,87,29],"Unruptured Intracranial Aneurysms","Cerebrovascular Event","Hemorrhagic Stroke","Methylprednisolone",[89,90,87,85],"Flow-diverter devices","Intracranial aneurysm","2026-01-17",{"date":64,"type":38},{"date":94,"type":22},"2026-01-30",{"date":96,"type":22},"2027-09-01",{"name":98,"class":45},"Duan Chuanzhi",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100481011","derivo-2heal-study-clinical-safety-and-efficacy-of-the-derivo-2heal-embolisation-device-100481011","NCT05543447","DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device","DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device for Intracranial Aneurysms","REheal","Inclusion Criteria:\n\n* Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU\n* Age \\> 18 years\n* Signed Informed Consent Form\n* Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device\n* Effective use of antiplatelet medication confirmed by applicable testing method according to local standard\n\nExclusion Criteria:\n\n* Previously treated aneurysms with flow diverter, stent or WEB device\n* Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient\n* Patient with a ruptured aneurysm in the acute phase of bleeding\n* Pre-treatment disability (mRS \\> 2)\n* Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel\n* Contraindication against treatment with anti-platelet medication\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study\n* Participating in another study",{"count":108,"type":22},158,"OBSERVATIONAL","To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.",[112,29],"Intracranial Aneurysm",[114,115,116],"Aneurysm","DERIVO","DERIVO 2 Heal","2025-08-27",{"date":119,"type":38},"2025-09-04",{"date":121,"type":38},"2022-12-15",{"date":123,"type":22},"2026-12",{"name":125,"class":126},"Acandis GmbH","INDUSTRY",17,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":46},"100588617","clinical-safety-and-efficacy-of-flow-diverter-in-the-treatment-of-intracranial-aneurysms-100588617","NCT06943729","Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms","Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms","Inclusion Criteria:\n\n1)18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome\u002Fneck ratio \\\u003C2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1)AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)\\>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)\\\u003C100×10\\^ 9 \u002FL or\u002Fand anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study.\n\nIntraoperative exclusion criteria: 1) acute rupture and hemorrhage of aneurysm during operation; 2) failure of FD implantation; 3) thrombosis in stent; 4) stent mal-apposition.","80 Years",{"count":137,"type":22},523,"To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.",[29],[29,112],"2025-08-22",{"date":143,"type":38},"2025-08-29",{"date":145,"type":38},"2025-04-27",{"date":147,"type":22},"2027-04-30",{"name":149,"class":45},"Huashan Hospital"]