[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-aneurysm":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,45,72,95,132,167,189,222,242,282,312,335,355,383,407,434,460,490,514,539,567,588,612,640,671],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609410","intravascular-neuro-oct-imaging-system-for-aneurysm-treatment-evaluation-100609410",false,"NCT07214220","Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation","INSYTE","Inclusion Criteria:\n\nSubject age ≥ 18 and ≤ 75 years\n\nSubject has a pre-procedure mRS ≤ 3\n\nSubject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured\n\nSubject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document\n\nParent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.\n\nExclusion Criteria:\n\nSubjects with a minimum platelet count of \\\u003C 100,000\u002FμL.\n\nSubjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days.\n\nSubject has an acutely ruptured aneurysm with a Hunt \\& Hess score ≥ 4\n\nSubject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography\n\nSubject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021\" catheter, including stenosis \\> 70% or excessive tortuosity\n\nSubject presents with other medical or surgical co-morbidities limiting his\u002Fher life expectancy to less than one year\n\nSubject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements.\n\nSubject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke\n\nSubject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication\n\nSubject has ipsilateral carotid or vertebral artery stenosis greater than 50%\n\nSubject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.\n\nSubject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk\n\nSubject has severe intracranial vasospasm not responsive to medical therapy\n\nSubject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis\n\nThe subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial\n\nSubject is currently participating in another clinical research trial involving an investigational device or drug\n\nSubject is under judicial protection or legal guardianship","ALL","18 Years","75 Years",{"count":21,"type":22},67,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices.\n\nThe nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing.\n\nThe objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.",[28],"Intracranial Aneurysm",[30,31],"Intracranial aneurysm treatment","OCT","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2026-02-25",{"date":40,"type":22},"2029-02-28",{"name":42,"class":43},"Spryte Medical","INDUSTRY",8,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100285637","the-artisse-intrasaccular-device-is-indicated-for-the-treatment-of-wide-neck-bifurcating-intracranial-aneurysms-ias-100285637","NCT02998229","The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).","Artisse™ Intrasaccular Device IDE","ARTISSE","Inclusion Criteria:\n\n1. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board\u002FEthics Committee (IRB\u002FEC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)\u002Fdata protection authorization has been provided and signed by the subject or subject's LAR.\n2. Subject is 18-75 years of age at the time of consent.\n3. Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.\n4. The target aneurysm must have the following characteristics:\n\n   1. Saccular morphology\n   2. Located at a bifurcation in the anterior or posterior circulation\n   3. Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.\n   4. Wide-necked, defined as neck size ≥ 4 mm and\u002For a dome-to-neck ratio of ≥ 1 and \\\u003C 2.\n5. If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II.\n\n   Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).)\n6. Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule).\n7. Subject meets one or more risk factors for IA rupture, such as age, hypertension, cigarette smoking, use of sympathomimetic drugs, Japanese or Finnish ancestry, history of prior aneurysmal subarachnoid hemorrhage (aSAH), familial intracranial aneurysms or SAH, clinical or radiological mass effect, reduced quality of life due to fear of rupture, IA size, location, and morphology, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.\n8. Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment\n9. If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).\n\nExclusion Criteria:\n\n1. During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.)\n2. Subject's target aneurysm was previously treated with other devices\u002Fimplants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisse™ Intrasaccular Device.\n3. Subject has a known active systemic bacterial infection.\n4. Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular Device by the treating physician.\n5. Subject has a mRS score \\> 2 (i.e., mRS scores of 3 to 5) prior to procedure (in case of unruptured IA) or prior to rupture (in case of ruptured IA).\n6. Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.\n7. Subject, of child-bearing potential, is pregnant (confirmed with a positive pregnancy test) or plans to become pregnant during the 1 year follow up period after the index procedure.\n8. Subject is enrolled in another device or drug study in which participation could confound study results.\n9. The treating physician determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.\n10. Subject has a known hypersensitivity, which cannot be medically treated, to any component of the study device, procedural materials, or medications commonly used during the procedure.\n11. Subject is taking anticoagulants (e.g., warfarin) that cannot be discontinued for a minimum of 7 days post-procedure or have a known blood dyscrasia, coagulopathy, or hemoglobinopathy.\n12. Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).\n13. Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.",{"count":54,"type":22},300,[25],"The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.",[28],[59,60,61],"Intracranial aneurysm","Intrasaccular","Artisse","2026-06-26",{"date":64,"type":36},"2026-06-30",{"date":66,"type":36},"2024-04-16",{"date":68,"type":22},"2032-02",{"name":70,"class":43},"Medtronic Neurovascular Clinical Affairs",22,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":82,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100562570","nv-psr-inspire-a-pipeline-vantage-post-approval-study-100562570","NCT06604884","NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study","Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA\u002Fdata protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.\n2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.\n3. Patient is an adult per local law at time of consent.\n\nExclusion Criteria:\n\n1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.\n2. Patient who may be unable to complete the study follow-up.\n3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.\n4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.\n5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug\u002Fdevice study that may confound the study results.","22 Years",{"count":81,"type":22},118,"5 Years","OBSERVATIONAL","The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) (\"Pipeline™ Vantage PAS\") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ (\"Pipeline™ Vantage Device\") in a post approval setting.",[28],"2026-06-22",{"date":88,"type":36},"2026-06-23",{"date":90,"type":36},"2025-12-12",{"date":92,"type":22},"2033-09",{"name":70,"class":43},7,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100172884","product-surveillance-registry-100172884","NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results",{"count":104,"type":22},100000,"The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[107,108,109,110,111,28,112,113,114,115,116,117,118,119,120,121],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Mechanical Circulatory Support","Respiratory Therapy","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","2026-06-15",{"date":124,"type":36},"2026-06-17",{"date":126,"type":4},"2012-01",{"date":128,"type":22},"2040-01",{"name":130,"class":43},"Medtronic",395,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":140,"targetDuration":142,"studyType":83,"phases":4,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":166},"100642500","real-world-study-of-woven-endobridge-for-intracranial-aneurysm-treatment-100642500","NCT07620626","Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment","A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms","WEB-RWS","Inclusion Criteria:\n\nRetrospective Cohort:\n\n* Participants of any age and sex.\n* Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.\n* Patients who completed at least one postoperative imaging follow-up.\n\nProspective Cohort:\n\n* Participants of any age and sex.\n* Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.\n* The participant, or legally authorized representative if applicable, understands the study requirements and procedures and provides written informed consent before any study-specific data collection.\n\nExclusion Criteria:\n\nRetrospective Cohort:\n\n* Patients treated with a Woven EndoBridge device for whom intraoperative or postoperative follow-up imaging data are not available.\n* Patients considered by the investigator to be unsuitable for participation in this study.\n\nProspective Cohort:\n\n* Participants who are currently participating in, or plan to participate during the follow-up period, another clinical study that may affect the results of this study.\n* Patients who are currently unable or expected to be unable to complete follow-up.\n* Patients with a life expectancy of less than 1 year due to other diseases or conditions.\n* Patients considered by the investigator to be unsuitable for participation in this study.",{"count":141,"type":22},1000,"12 Months","We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.",[28],[146,147,148,149,28,150,151,152,153,154,155],"Woven EndoBridge","WEB Device","Intrasaccular Flow Disruption","Endovascular Treatment","Aneurysm Embolization","Real-World Study","Post-Market Study","Raymond-Roy Occlusion Classification","WEB Occlusion Scale","Active surveillance","2026-06-09",{"date":158,"type":36},"2026-06-11",{"date":160,"type":22},"2026-06-10",{"date":162,"type":22},"2028-06-30",{"name":164,"class":165},"Xuanwu Hospital, Beijing","OTHER",1,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100610494","a-study-of-choydar-flow-directed-mesh-stent-in-the-treatment-of-unruptured-intracranial-aneurysms-100610494","NCT07228312","A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms","A Multicenter, Prospective, Single-Arm Observational Study to Evaluate the Safety and Effectiveness of the Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms","CROWN","Inclusion criteria:\n\nParticipants meeting all the following inclusion criteria will be included:\n\nPreoperative inclusion criteria:\n\n* Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to \\[\\>=\\] 4 millimeters \\[mm\\] or dome-to-neck ratio less than \\[\\\u003C\\] 2) saccular or fusiform aneurysms, and the parent artery diameter must be \\>= 2.0 mm and less than or equal to \\[\\\u003C=\\] 6.0 mm\n* Participants and\u002For their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF)\n* Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent\n* Participants who are willing and able to return for all follow-up visits as required by the study protocol\n\nIntraoperative inclusion criteria:\n\n\\- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width \\>= 4 mm or dome-to-neck ratio \\\u003C2) saccular or fusiform aneurysms, and the parent artery diameter must be \\>= 2.0 mm and \\\u003C= 6.0 mm\n\nExclusion criteria:\n\nParticipants meeting any of the following exclusion criteria will be excluded:\n\n* Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed)\n* Participants who are allergic to contrast media\n* Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy\n* Participants who are contraindicated for antiplatelet and\u002For anticoagulant therapy\n* Participants with active bacterial infections\n* Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care\n* Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and\u002For epidemiological studies that do not require interventions)",{"count":176,"type":22},200,"The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.",[28],"2026-06-04",{"date":181,"type":36},"2026-06-05",{"date":183,"type":36},"2026-01-28",{"date":185,"type":22},"2028-02-10",{"name":187,"class":43},"Johnson & Johnson Medical (Shanghai) Ltd.",3,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":82,"studyType":83,"phases":4,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100284863","neurovascular-product-surveillance-registry-100284863","NCT02988128","Neurovascular Product Surveillance Registry","NeuroVascular Product Surveillance Registry (PSR) Platform","INSPIRE","For MDT16056 and MDT17077\n\nInclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements\n* Patient has, or is intended to receive or be treated with, an eligible Medtronic product\n* Patient is consented within the enrollment window of the therapy received, as applicable\n* Patient is at least 18 years of age at time of enrollment.\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.\n\nFor MDT24028 and MDT22032:\n\nGeneral Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements.\n* Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.\n* Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template\n\nGeneral Exclusion Criteria:\n\n* Patient who may be unable to complete the study follow-up\n* Patient with any contraindications per the applicable Instructions for Use document\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study\n* Patient is currently enrolled in, or plans to enroll in, any concurrent drug\u002Fdevice study that may confound the study results.\n\nAdditional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.",{"count":198,"type":22},4000,"Post market surveillance registry",[28,201],"Stroke, Ischemic",[203,204,205,206,207,208,209,210,211,212],"Embolization Device","Flow Diverter","Intrasaccular device","Vascular Reconstruction Device","Ruptured Intracranial Aneurysm","Unruptured Intracranial Aneurysm","Large Vessel Occlusion","Stent Retriever","Aspiration Catheter","Revascularization Device","2026-05-31",{"date":215,"type":36},"2026-06-02",{"date":217,"type":36},"2016-12",{"date":219,"type":22},"2032-08",{"name":70,"class":43},99,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":166},"100561313","patient-specific-planning-of-minimally-invasive-brain-interventions-based-on-vascular-hemodynamic-mapping-100561313","NCT06588543","Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping","Inclusion Criteria:\n\n* Subjects who are diagnosed with aneurysm or arteriovenous malformation\n* Subjects who are treated (or will be treated) with endovascular embolization and\u002For arteriovenous coiling\n* During and before\u002Fafter the subject's intervention, medical images (MRI, 3D rotational angiography, DSA) were collected of the cerebral arterial vascular tree (which can be used to develop patient-specific models), including catheter location and use of contrast fluid to visualize the cerebral to make the arterial tree more visible.\n\nExclusion Criteria:\n\n-Procedures during which no imaging was performed",{"count":229,"type":22},500,"Endovascular procedures for treating brain aneurysms and arteriovenous malformations (AVMs) are becoming increasingly popular due to their less invasive nature and lower risk of complications. However, they still face challenges such as difficult catheter navigation and incomplete embolization.\n\nThis study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies. These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics (CFD) and artificial intelligence (AI) models to simulate blood flow. By using these models, interventional radiologists can better plan catheter navigation and predict embolization outcomes. This could lead to faster, more accurate procedures with reduced radiation exposure for patients.",[28,232],"Arteriovenous Malformations, Cerebral","2026-05-08",{"date":235,"type":36},"2026-05-13",{"date":237,"type":36},"2024-08-13",{"date":239,"type":22},"2030-12-31",{"name":241,"class":165},"University Hospital, Ghent",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":250,"targetDuration":251,"studyType":83,"phases":4,"briefSummary":252,"conditions":253,"keywords":258,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":166},"100554080","microvention-aneurysm--stroke-real-life-data-collection-100554080","NCT06494436","Microvention AnEurysm & STroke Real-life Data cOllection","Microvention Aneurysm & Stroke Real-life Data Collection","MAESTRO","Inclusion criteria:\n\n* Patient, or another authorized person as per country-specific regulations, is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.\n* For Cohort 1, patient is treated for a ruptured or unruptured intracranial aneurysm using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.\n* For Cohort 2, patient is treated using a commercially available MicroVention mechanical thrombectomy device as the first-line treatment strategy and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.\n\nNote: For the purposes of this protocol, ancillary\u002Faccessory devices such as balloon catheters, carotid stent for extracranial stenosis and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.\n\nExclusion Criteria:\n\n* Patient is or is expected to be inaccessible for follow-up.\n* Patient is participating or intends to participate in another study that changes the site practice.\n* Patient is already participating in the MAESTRO study for the same pathology.",{"count":141,"type":22},"18 Months","The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry",[28,254,255,256,257],"Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion","Aneurysmal Subarachnoid Hemorrhage","Ischemic Stroke","Acute Ischemic Stroke",[259,260,261,262,263,264,265,266,267,268,269,270,271,272],"endovascular treatment","stent","flow diverter","hydrocoil","coil","implantable device","FRED","LVIS","WEB","Mechanical Thrombectomy","Aspiration","SOFIA","ERIC","BOBBY","2026-02-05",{"date":275,"type":36},"2026-02-09",{"date":277,"type":36},"2024-12-30",{"date":279,"type":22},"2030-06-30",{"name":281,"class":43},"Microvention-Terumo, Inc.",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":289,"targetDuration":291,"studyType":83,"phases":4,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":166},"100620139","cerebral-arteriovenous-malformation-with-aneurysm-epidemiology-clinical-features-and-prognosis-100620139","NCT07353736","Cerebral Arteriovenous Malformation With Aneurysm: Epidemiology, Clinical Features, and Prognosis","Hemodynamic Mechanisms, Clinical Profiles, and Prognostic Factors in Patients With Cerebral Arteriovenous Malformations and Intracranial Aneurysms: An Observational Cohort Study","Inclusion Criteria:\n\n* Patients diagnosed with cerebral arteriovenous malformation and intracranial aneurysm confirmed by CTA, MRA, and\u002For DSA;\n* Availability of complete clinical and imaging data;\n* Provision of written informed consent by the patient or their legally authorized representative to participate in the study and undergo follow-up;\n* Not concurrently participating in any other clinical trials that may interfere with the outcomes of this study.\n\nExclusion Criteria:\n\n* Previous complete occlusion of the aneurysm and\u002For arteriovenous malformation prior to enrollment;\n* Coexistence of other cerebrovascular diseases such as moyamoya disease, cerebral cavernous malformation, cerebral venous sinus thrombosis, etc.;\n* Absence of DSA imaging data or poor image quality that precludes accurate evaluation of key anatomical and hemodynamic parameters of the AVM and intracranial aneurysm.",{"count":290,"type":22},630,"2 Years","The study is a multicenter, prospective cohort study designed to assess the natural history, clinical safety and efficacy of various treatment strategies in patients with cerebral arteriovenous malformations (AVMs) and intracranial aneurysms.",[294,295,296,28,297],"Cerebral Arteriovenous Malformation","Intracranial Arterial Diseases","Intra Cerebral Hemorrhage","Brain Diseases",[299,300,301,294,28],"Hemodynamic Mechanisms","Prospective cohort study","Endovascular treatment","NOT_YET_RECRUITING","2026-01-17",{"date":305,"type":36},"2026-01-20",{"date":307,"type":22},"2026-02-01",{"date":309,"type":22},"2030-12-30",{"name":311,"class":165},"Duan Chuanzhi",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":320,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":323,"studyType":83,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":71},"100479697","neurist--intregrated-biomedical-informatics-for-the-management-of-cerebral-aneurysms-100479697","NCT05526352","@neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms","@neurIST : Informatique biomédicale intégrée Pour la Gestion Des anévrismes cérébraux","@neurIST","Inclusion Criteria:\n\n* able to provide consent or, in the event that a patient is incapable of providing consent, that a person is legally authorized to do so on behalf of the patient according to legal and ethical requirements of the country where the clinical centre is located.\n\nPatients:\n\n* must have an angiographically proven intracranial aneurysm (MRA\\\u003C CTA\\\u003C DSA accepted).The determination of SAH requires the presence of a subarachnoid haemorrhage be verified on CT or by lumbar puncture.\n\nMRA: Magnetic Resonance Angiography CTA: Computed Tomography Angiography DSA: Digital Subtracted Angiography\n\nExclusion Criteria:\n\n* failure of a candidate to contribute clinical data,\n* refusal to provide informed consent.",true,{"count":322,"type":22},20000,"25 Years","The primary aim of the SwissNeuroFoundation AneurysmDataBase Project is to implement information technology based tools to create and use a holistic reference database specific to intracranial aneurysms (IA).\n\nThe SwissNeuroFoundation AneurysmDataBase are concerned with generating the data with which to populate this database.\n\nThe purpose for populating the database are to:\n\n* Screen for and evaluate markers of risk for intracranial aneurysm formation and aneurysm rupture. Are considered as markers the following: genetics factors, microbiota, environmental factors, congenital factors (ie: cerebrovascular anatomical variants), transcriptomics signature, proteomics signature,shape characteristics, haemodynamics characteristics.\n* Screen for and evaluate prognostic factors of outcome regarding different management strategies including watchful observation, microsurgical treatment, endovascular treatment or any combination thereof.\n* Implement and evaluate patient-specific management protocols integrating all available information.\n* Evaluate the impact of the database and use of tools to improve care, reduce costs, support knowledge discovery and promote new industrial developments.",[28],"2026-01-14",{"date":328,"type":36},"2026-01-16",{"date":330,"type":36},"2015-06-01",{"date":332,"type":22},"2040-03-01",{"name":334,"class":165},"University Hospital, Geneva",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":166},"100619033","safety--performance-of-the-world-medica-world-diverter-embolization-device-100619033","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","80 Years",{"count":343,"type":22},72,[25],"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.",[28],"2026-01-13",{"date":326,"type":36},{"date":350,"type":22},"2026-03-31",{"date":352,"type":22},"2028-08-31",{"name":354,"class":43},"World Medica USA, LLC",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100529511","international-registry-of-intra-arterial-and-endosaccular-flow-diverters-irf-100529511","NCT06174727","International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)","Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)","IRF","Inclusion Criteria:\n\n* Adult patients (18 years of age or older)\n* Underwent endovascular treatment with one of the following devices:\n\n  a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada)\n\n  b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna\u002FArtisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)\n* Complete medical records and follow-up data available\n\nExclusion Criteria:\n\n* Incomplete procedural or follow-up records\n* Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)\n* Aneurysms treated with investigational devices not listed within Inclusion Criteria",{"count":364,"type":22},5000,"This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.",[28],[368,369,370,371,372],"Endovascular","Registry","Flow Diverter Stents","Endosaccular Flow Disruptors","Flow Diversion","2026-01-05",{"date":375,"type":36},"2026-01-07",{"date":377,"type":36},"2023-10-01",{"date":379,"type":22},"2026-06",{"name":381,"class":165},"Montefiore Medical Center",11,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":166},"100525114","placental-learning-model-for-neurovascular-microsurgery-for-the-management-of-intracranial-aneurysms-100525114","NCT06117527","Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms","NeuroVasc","Inclusion criteria:\n\n* Woman over the age of 18;\n* Placenta considered as surgical waste intended for incineration; with a negative infectious status verified during pregnancy follow-up\n* Woman who did not express her opposition, after information, to the reuse of her placenta for educational purposes to improve the practical training of future neurosurgeons.\n\nExclusion criteria:\n\n* Subject who expressed their opposition to participating in the study\n* Subject under guardianship or curatorship\n* Subject under safeguard of justice",{"count":391,"type":22},50,"Training in microsurgical techniques for the management of intracranial aneurysms is carried out during the practical training of the DES in Neurosurgery and during the continuous training of neurosurgeons according to the indications of the patients of the department. Currently, the recent increase in indications for endovascular treatment compared to surgical indications has led to a decrease in surgical indications and in the experience of neurosurgeons. However, there are still surgical indications that are often complex situations that neurosurgeons must overcome with a specific simulation approach.\n\nThere are different simulation models for the treatment of intracranial aneurysms. The small animal (rodent) model has the disadvantage of being poorly suited to the reproduction of intracranial aneurysms (different extracranial vessel walls, too small intracerebral vessel caliber) and of being constraining to the establishment. The computerized stimulator model which has the advantage of being able to reproduce the anatomy of a patient but whose haptic sensitivity performance is difficult to reproduce for very fine movements, it is not very accessible because it is expensive. The placental model uses a fresh human placenta, the appearance of the vessels of which is very similar to those found intracerebrally, and dilations on their walls can be performed with a pediatric urinary catheter.",[28],[59,395,396,397],"Placental learning model","Neurovascular microsurgery","Aneurysm","2025-12-18",{"date":400,"type":36},"2025-12-26",{"date":402,"type":36},"2020-07-16",{"date":404,"type":22},"2028-02",{"name":406,"class":165},"University Hospital, Strasbourg, France",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":341,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":166},"100548104","general-anesthesia-vs-local-anesthesia-for-endovascular-treatment-in-patients-with-unruptured-intracranial-aneurysm-using-flow-diverter-100548104","NCT06416657","General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter","General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial","GALA-FD","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤80 years old, gender is not limited;\n2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;\n3. UIA maximum diameter \\\u003C15mm;\n4. Baseline mRS score ≤2;\n5. UIAs planned for treated with PED;\n6. Patients voluntarily participated in this study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;\n2. Those who are allergic to any components of the anesthetic drugs;\n3. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;\n4. Pregnant and lactating female patients;\n5. Severe hepatic dysfunction (ALT or AST \\>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \\\u003C30 mL\u002Fmin) before randomisation;\n6. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);\n7. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;\n8. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;\n9. Patients who are participating in clinical trials of other drugs or devices;\n10. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.",{"count":416,"type":22},188,[25],"The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.",[28],[421,422,423,424],"Unruptured intracranial aneurysm","Flow diverter","General anesthesia","Local anesthesia","2025-11-25",{"date":427,"type":36},"2025-12-02",{"date":429,"type":36},"2024-06-01",{"date":431,"type":22},"2026-06-01",{"name":433,"class":165},"Ming Lv",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":320,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100525215","ideal-study-blinded-rct-for-the-impact-of-ai-model-for-cerebral-aneurysms-detection-on-patients-diagnosis-and-outcomes-100525215","NCT06118840","IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes","Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patients' Diagnosis and Outcomes: The IDEAL Study - A Web-Based Multicenter, Double-Blinded Randomized Controlled Trial","IDEAL","Inclusion Criteria:\n\n* Adult inpatients and outpatients who are scheduled for head CTA scanning.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Patients with contraindications to CTA.\n* Modified Rankin Scale (mRS) score \\> 3.\n* Refuse to sign informed consent.\n* Participation in other clinical studies of intracranial aneurysms.\n* Patients with failed head CTA scanning or incomplete image data, or poor image quality.",{"count":443,"type":22},6450,[25],"This study (IEDAL study) intends to prospectively enroll more than 6450 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 21 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.",[28,447,448,449],"CT Angiography","Deep Learning","Double Bind Interaction","2025-10-01",{"date":452,"type":36},"2025-10-07",{"date":454,"type":36},"2024-05-20",{"date":456,"type":22},"2026-12",{"name":458,"class":165},"Jinling Hospital, China",21,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":291,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":470,"conditions":471,"keywords":477,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":489},"100433671","safety-performance-and-usability-of-balt-medical-devices-the-evidence-post-marketing-clinical-follow-up-platform-100433671","NCT04927156","Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform","Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection","EVIDENCE","Inclusion Criteria:\n\n* Provision of a signed, written and dated informed consent or non-opposition (where applicable)\n\nExclusion Criteria\n\n* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)\n* Contra-indications of each device as described in the instructions for use.",{"count":469,"type":22},10000,"BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.\n\nThis platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.",[28,472,257,473,474,475,476],"Brain Arterial Disease","Peripheral Vascular Diseases","AVM - Cerebral Arteriovenous Malformation","AVM","Fistulas Arteriovenous",[478,479],"catheter","guidewire","2025-09-16",{"date":482,"type":36},"2025-09-18",{"date":484,"type":36},"2021-07-12",{"date":486,"type":22},"2041-10",{"name":488,"class":43},"Balt Extrusion",12,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":513},"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":499,"type":22},158,"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.",[28,204],[397,503,504],"DERIVO","DERIVO 2 Heal","2025-08-27",{"date":507,"type":36},"2025-09-04",{"date":509,"type":36},"2022-12-15",{"date":456,"type":22},{"name":512,"class":43},"Acandis GmbH",17,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":320,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":529,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":4},"100602523","stepped-wedge-cluster-randomized-trial-of-ai-assisted-cta-detection-for-intracranial-aneurysms-in-regional-hospitals-100602523","NCT07124624","Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals","Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial","IDEAL2","Inclusion Criteria:\n\n-Patients in the outpatient setting who are scheduled to undergo head CTA scanning\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)\n* Modified Rankin Scale (mRS) score \\> 3\n* Refuse to sign written informed consent\n* Contraindications to CTA examination\n* CTA scan failure, incomplete imaging data, or image quality insufficient for diagnostic evaluation",{"count":523,"type":22},14400,[25],"This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.",[28,447,527,528],"AI (Artificial Intelligence)","Cluster Randomized Trial",[59,527,530],"Stepped-wedge cluster-randomized trial","2025-08-15",{"date":533,"type":36},"2025-08-20",{"date":535,"type":22},"2025-10-09",{"date":537,"type":22},"2029-08-31",{"name":458,"class":165},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":554,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":566},"100374449","comprehensive-aneurysm-management-trial-100374449","NCT04155606","Comprehensive Aneurysm Management Trial","The Comprehensive Aneurysm Management Trial","CAM","Inclusion Criteria:\n\n* Patients with at least one documented, intracranial subarachnoid aneurysm (cavernous aneurysms are excluded)\n\nExclusion Criteria:\n\n* Patients with any intracranial hemorrhage, including SAH, within the previous 30 days\n* Patients with AVM-associated aneurysms\n* Patients unable to give informed consent",{"count":548,"type":22},2000,[25],"The uncertainty regarding the management of Unruptured Intracranial Aneurysms (UIAs) has not progressed in the last 30 years. The fundamental ethical basis for this study is that physicians should only offer a risky preventive treatment when it has been shown to be beneficial. Before that, such treatment should be offered as an RCT. The CAM trial offers a comprehensive framework, so that all patients confronted with the clinical dilemma can be offered participation.\n\nThe principal questions to be addressed are :\n\n1. do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management?\n2. when patients are considered ineligible for conservative management, and surgical and endovascular management are both judged reasonable, do patients with UIAs have a better long-term clinical outcome with surgical or endovascular management? The primary hypothesis for patients allocated to at least 2 options, one of which is conservative management is: the 10 year combined neurological morbidity and mortality (mRS\\>2) will be reduced from 24% to 16% (beta 80%; alpha 0.048; sample size 961 patients (836 plus 15% losses to FU and cross-overs) with active treatment.\n\nThis study is designed as a pragmatic, comprehensive way to address the unruptured aneurysm clinical dilemma, combining large simple RCTs whenever patients are judged eligible for more than one management option, or otherwise a registry of each option. All patients with one or more UIAs will be eligible for participation in either a registry or one of the trials. Patients will be followed for 10 years according to a standard of car follow-up schedule.\n\nThe primary outcome is survival without neurological dependency (mRS\\\u003C3) at 10 years.\n\nThe secondary outcomes are:\n\n1. the incidence of SAH during follow-up and related morbidity and mortality;\n2. the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year;\n3. overall mortality at 1, 5 and 10 years;\n4. overall morbidity (mRS\\>2) at 1, 5 and 10 years;\n5. length of hospitalization;\n6. discharge to location other than home",[552,28,553],"Saccular Aneurysm","Unruptured Cerebral Aneurysm",[208,301,555,556],"Surgical treatment","Conservative management","2025-07-23",{"date":559,"type":36},"2025-07-28",{"date":561,"type":36},"2020-01-15",{"date":563,"type":22},"2036-01",{"name":565,"class":165},"Centre hospitalier de l'Université de Montréal (CHUM)",6,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":265,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":4},"100591619","fred-retrospective-study-of-intracranial-aneurysms-treatment-100591619","NCT06982781","FRED Retrospective Study of Intracranial Aneurysms Treatment","A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms","Inclusion Criteria:\n\n* People in China mainland who have been treated with FRED. The patients for whom clinical data are available\n\nExclusion Criteria:\n\n* Patients who met the inclusion criteria at all time points were required to be included in the study. Therefore, no specific exclusion criteria were set.","90 Years",{"count":548,"type":22},"To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment",[28],[579],"Intracranial Aneurysms","2025-05-20",{"date":582,"type":36},"2025-05-21",{"date":584,"type":22},"2025-05",{"date":586,"type":22},"2027-05-06",{"name":281,"class":43},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":166},"100519776","brain-low-risk-aneurysm-stereotactic-radiosurgical-trial-100519776","NCT06047951","Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial","Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial: A Phase 2 Nonrandomized Controlled Trial","BLAST","Inclusion Criteria:\n\n* Medical imaging (CTA, MRA or digital substraction angiography) reveals the existence of an asymptomatic unruptured saccular anterior circulation intracranial aneurysm under 7 mm\n* Advised by a vascular neurosurgeon to observe rather than undergo endovascular or microsurgical management\n\nExclusion Criteria:\n\n* Prior history of aneurysmal rupture\n* Presence of symptoms that could be attributed to the aneurysm (severe headache, third cranial nerve deficits, or others)\n* Imaging features deemed to increase rupture risk as evaluated by the treating physician\n* Posterior circulation aneurysm\n* Fusiform aneurysm\n* Dissecting aneurysm\n* Mycotic aneurysm\n* Direct contact between the aneurysm and the optic pathways on medical imaging\n* Prior coils or clips in the targeted aneurysm or any other aneurysm\n* Patient unable to consent\n* Patient unable or unlikely to comply with the follow-up schedule",{"count":597,"type":22},40,[25],"The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans.\n\nParticipants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions:\n\nDay 0\n\n* Initial questionnaire\n* CTA scan\n* MRI\n* Radiosurgery performed on patients in the radiosurgery group\n\n  6 months\n* CTA scan\n* Follow-up questionnaire\n\n  12 months\n* CTA scan\n* MRI\n* Follow-up questionnaire\n\n  24 months\n* CTA scan\n* Follow-up questionnaire\n\n  36 months\n* CTA scan\n* MRI\n* Follow-up questionnaire\n\nResearchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.",[28],[602],"brain aneurysm, radiosurgery, intracranial aneurysm","2025-02-12",{"date":605,"type":36},"2025-02-14",{"date":607,"type":22},"2025-06",{"date":609,"type":22},"2030-06",{"name":611,"class":165},"Dr David Mathieu",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":341,"enrollmentInfo":620,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":621,"conditions":622,"keywords":627,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":166},"100513636","detection-of-microplastics-and-nanoplastics-in-neurosurgery-patients-dt-mini-100513636","NCT05968053","Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)","Presence of Microplastics and Nanoplastics in Neurosurgery Patients","DT-MiNi","Inclusion Criteria:\n\n* Age 18-80 years\n* Any type of neurosurgery\n\nExclusion Criteria:\n\n·refusal of the patient to participate",{"count":229,"type":22},"Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.\n\nNeurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.\n\nThe objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.",[623,624,28,625,626],"Carotid Artery Stenosis","Glioma","Intracranial Hemorrhages","Brain Tumor",[628,629,28,630,623],"microplastics","nanoplastics","brain tumor","2025-01-21",{"date":633,"type":36},"2025-01-23",{"date":635,"type":36},"2023-09-25",{"date":637,"type":22},"2025-12-31",{"name":639,"class":165},"Beijing Tiantan Hospital",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":655,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":670},"100357638","the-rise-trial-a-randomized-trial-on-intra-saccular-endobridge-devices-100357638","NCT03936647","The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices","RISE","Inclusion Criteria:\n\n* patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician\n* aneurysm of maximum diameter of 4-11 mm\n* may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms\n* Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.\n* Ruptured aneurysms with WFNS ≤ 3\n\nExclusion Criteria:\n\n* Absolute contraindication to surgery, endovascular treatment or anesthesia\n* Patients unable to give informed consent\n* diameter of the aneurysm ≤ 4 mm but ≥ 11 mm\n* Ruptured aneurysms with WFNS 4 or 5",{"count":648,"type":22},250,[25],"Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.",[28,652,553,653,654],"Brain Aneurysm","Ruptured Cerebral Aneurysm","Cerebral Aneurysm",[656,657,658,659,660,661,662],"intracranial aneurysm","cerebral aneurysm","brain aneurysm","unruptured cerebral aneurysm","ruptured cerebral aneurysm","WEB embolization device","embolization",{"date":664,"type":36},"2024-08-15",{"date":666,"type":36},"2019-07-18",{"date":668,"type":22},"2026-01",{"name":565,"class":165},4,{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":341,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":166},"100528232","to-evaluate-the-safety-and-efficacy-of-intracranial-stent-assisted-endovascular-treatment-of-intracranial-aneurysms-100528232","NCT06158087","To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms","Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of Intracranial Aneurysms","Inclusion Criteria:\n\n* Aged from 18 to 80 years, male or female;\n* Patients diagnosed as wide-neck intracranial aneurysms by brain CTA\u002FMRA\u002FDSA (neck width≥4mm or bodyor a dome-to-neck ratio\\\u003C2);\n* Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;\n* Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;\n* The mRS Score of the patients was 0-2;\n* Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.\n\nExclusion Criteria:\n\n* Patients who have contraindications to antiplatelet and\u002For anticoagulant therapy or do not start antiplatelet therapy in time before treatment.\n* Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography.\n* Known to be allergic to Nitinol platinum alloy and angiographic agents.\n* Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation.\n* Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma.\n* The target aneurysm has previously received intravascular embolization or stent implantation treatment;\n* Multiple aneurysms or complex aneurysms;\n* Patients with acute ruptured aneurysm;\n* Serious infection is not controlled and is not suitable for operation;\n* Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;\n* Obvious abnormal coagulation function or bleeding tendency;\n* Combined with severe renal insufficiency, creatinine greater than or equal to 200umol\u002FL; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;\n* Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;\n* Participation in any other clinical trial within 30 days prior to signing informed consent;\n* Other conditions considered by the investigator to be inappropriate for enrollment.",{"count":679,"type":22},130,[25],"The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.",[28],"2024-06-26",{"date":685,"type":36},"2024-06-27",{"date":687,"type":36},"2023-12-29",{"date":689,"type":22},"2026-06-20",{"name":691,"class":43},"Shanghai Wallaby Medical Technologies Co.,Inc."]