[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"saccular-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:saccular-aneurysm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,85,109,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100603938","the-use-of-p4864-mw-hpc-flow-modulation-device-in-the-treatment-of-wide-necked-intracranial-aneurysms-100603938",false,"NCT07143019","The Use of p48\u002F64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms","p48\u002F64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.","PIANO","Inclusion Criteria:\n\n1. Subject is ≥ 18 years\n2. Subject has a mRS ≤2 before the index procedure\n3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:\n\n   1. Saccular or fusiform morphology\n   2. Located in the internal carotid artery and its branches\n   3. Aneurysm neck ≥4 mm or dome-to-neck ratio \\\u003C2\n   4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA\n4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.\n\nExclusion Criteria:\n\n1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated\n2. Any other known IA requiring treatment within 3 months post-procedure\n3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure\n4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation\n5. Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure\n6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm\n7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date\n8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)\n9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically\n10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components\n11. Irreversible bleeding disorder and\u002For signs of active bleeding at subject presentation\n12. Known renal failure with a serum creatinine \\>2.5 mg\u002Fdl (or 220 μmol\u002Fl) not on dialysis\n13. Contraindication to CT scan, MRI, or angiography\n14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)\n15. Known coagulopathy, or an admission International Normalized Ratio \\>3.0 without oral anticoagulation therapy, or an admission platelet count of \\\u003C100000\n16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial\n17. Unable to complete the required study follow-ups\n18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)\n19. Participating in another clinical trial that could affect participation or primary outcomes of this study\n20. Women currently pregnant or wish to become pregnant during the study or breast feeding.","ALL","18 Years",{"count":20,"type":21},214,"ESTIMATED","INTERVENTIONAL",[24],"NA","To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.",[27,28,29,30,31],"Hemorrhagic Stroke","Aneurysm, Intracranial","Saccular Aneurysm","Fusiform Aneurysm","Brain Aneurysm",[33,34,35,36,37,38,39,40],"Neurovascular Intervention","phenox","Brain","Unruptured Aneurysm","Flow diversion","Flow diverter","Occlusion","Flow modulation device","RECRUITING","2026-06-22",{"date":44,"type":45},"2026-06-25","ACTUAL",{"date":47,"type":45},"2026-03-16",{"date":49,"type":21},"2032-07",{"name":51,"class":52},"phenox Inc.","INDUSTRY",21,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":65,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100628684","pc400-coils-for-treatment-of-intracranial-aneurysms-100628684","NCT07464847","PC400 Coils for Treatment of Intracranial Aneurysms","Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study","PC400","Inclusion Criteria:\n\n* Subject is ≥ 18 and ≤ 80 years of age.\n* Subject has a previously untreated, ruptured or unruptured, saccular intracranial aneurysm 5mm or more in diameter for which the clinical decision to treat with Penumbra PC400 embolization coils has been made independent of the decision to enroll the subject in the study described in this protocol.\n* The decision to undergo the coiling procedure is made independently of and prior to participation in the research.\n* Subject has a baseline Hunt and Hess Score of I, II, or III.\n* Subject must be considered by the treating physician to be available for and able to complete all follow-up visits.\n* Subject has not been previously entered into this study.\n\nExclusion Criteria:\n\n* Subject is \\\u003C 18 or \\> 80 years of age.\n* Subject has a baseline Hunt and Hess score of IV or V.\n* Target aneurysm is dissecting, fusiform, blister-like, mycotic, tumoral, or AVM related.\n* Target aneurysm maximum diameter is \\\u003C5mm\n* Target aneurysm was previously treated via clipping or coiling.\n* Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques.\n* Target aneurysm has not been confidently determined by the treating physician to be the source of SAH.\n* Planned use of a flow diverter (Surpass, Pipeline, Silk, FRED, p64, etc.) or intrasaccular device (WEB, Artis, Medina, etc.) as a component of the target aneurysm treatment plan.\n* Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless stent is used for bailout purposes.\n* Subject has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.\n* Subject has a contraindication to heparin or aspirin.\n* Subject has vascular anatomy\u002Ftortuosity preventing access to the target aneurysm.\n* Subject is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician.\n* Subject has a serious or life-threatening comorbidity that could confound study results.\n* Subject is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.\n* Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.\n* Subject is pregnant, breastfeeding, or plans to become pregnant prior to completion of follow-up.\n* Subject is enrolled in another device or drug study in which participation could confound study results.","80 Years",{"count":64,"type":21},100,"18 Months","OBSERVATIONAL","The goal of this prospective, observational study is to evaluate the long-term occlusion rates and safety of the Penumbra PC400 coil in the treatment of ruptured and unruptured intracranial aneurysms in adult subjects ages 18-80.\n\nSpecifically, the study aims to analyze rate of death, stroke, neurological death, or rebleeding associated with the treatment of intracranial aneurysm with the PC400 coil.\n\nParticipants will undergo standard of care treatment and follow up for their aneurysm treatment, and participating sites will collect procedural and follow up data.",[69,29],"Intracranial Aneurysms",[71,72],"Intracranial aneurysm","Coiling","NOT_YET_RECRUITING","2026-03-09",{"date":76,"type":45},"2026-03-11",{"date":78,"type":21},"2026-05",{"date":80,"type":21},"2029-12",{"name":82,"class":83},"Semmes-Murphey Foundation","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":84},"100612856","lumens-1-canada-early-feasibility-study-clinical-investigation-plan-100612856","NCT07259018","LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan","A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured Intracranial Aneurysms.","Inclusion Criteria:\n\n1. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA \u002F ASA Guidelines.\n2. Age 18-80 years at screening\n3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs\n4. The IA must have had the following characteristics:\n\n   * IA located in bifurcation in the anterior or posterior circulation\n   * IA dimensions appropriate for treatment with LuSeed- Vascular Embolization Device per implant size selection guidelines as outlined in the Instructions for\n\n   Use (IFU) and as follows:\n   * IA Width: 2.5-5.5\\[mm\\]\n   * IA Neck: 2.0-5.0\\[mm\\]\n   * IA Height: min 4.0 \\[mm\\]- device short configuration, min 5.0 \\[mm\\]-device long configuration • The AI must meet the definition of a \"wide-neck\" aneurysm.\n5. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements\n6. Patient able to give their informed consent can be included in this study.\n\nExclusion Criteria:\n\n1. Ruptured intracranial aneurysm\n2. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab\n3. Contraindication for arterial access\n4. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm\n5. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm\n6. Intracranial aneurysm minimum height less than 4.0 mm\n7. Target Intracranial aneurysm contains other devices\u002Fimplants (e.g., coils)\n8. Stenosis of the target IA's parent vessel \\>50%\n9. Known allergy to platinum, nickel, or titanium\n10. Known allergy to contrast agents\n11. Absolute contraindication to anticoagulation or antiplatelet therapy\n12. Anticoagulation medications such as warfarin that cannot be discontinued\n13. Pregnant, breastfeeding or planning pregnancy within next 12 months\n14. Acute or chronic renal failure (stage III or IV by VARC-3 criteria)\n15. Cerebral embolism, stroke, or TIA in past 6 months\n16. Myocardial infarction in the past 6 months\n17. Any other medical issue within the brain that would preclude device implantation (such as brain surgery, radiation in the target area of intervention from an external beam source, acute traumatic craniocerebral injury, etc.)\n18. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.\n19. Patient had physical, neurologic or psychiatric conditions which precluded his\u002Fher ability to comply with all aspects of the screening, evaluation, treatment, and the postprocedure follow-up schedule.\n20. Other medical conditions that cause an inability to comply with study requirements and\u002For that could increase the risk of neurovascular procedures (e.g., extreme frailty, liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)\n21. Patient had a life expectancy of less than 12 months.\n22. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.",{"count":93,"type":21},10,[24],"The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.",[97,98,99,29,31],"Aneurysm Cerebral","Bifurcation","Unruptured Intracranial Aneurysm","2025-12-02",{"date":102,"type":45},"2025-12-09",{"date":104,"type":21},"2025-12",{"date":106,"type":21},"2028-05",{"name":108,"class":52},"LuSeed Vascular LTD.",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100574598","lumens-1-eu-efs-cip-100574598","NCT06761365","LUMENS-1 EU EFS CIP","A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS","Inclusion Criteria:\n\n* Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA \u002F ASA Guidelines.\n\n  1. Age 18-80 years at screening\n  2. Patients who are suitable for non-emergency endovascular embolization of saccular IAs\n  3. The IA must have had the following characteristics:\n* IA located in the anterior or posterior circulation\n* IA dimensions appropriate for treatment with\n\nLuSeed-Vascular Embolization Device per implant size selection guidelines as outlined in the Instructions for Use (IFU) and as follows:\n\n* IA Width: 2.5-5.5\\[mm\\]\n* IA Neck: 2.0-5.0\\[mm\\]\n* IA Height: min 4.0 \\[mm\\]- device short configuration, min 5.0 \\[mm\\]-device long configuration 4. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements Exclusion Criteria: 5. Patient able to give their informed consent can be included in this study. Exclusion Criteria\n\n  1. Ruptured intracranial aneurysm\n  2. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab\n  3. Contraindication for arterial access\n  4. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm\n  5. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm\n  6. Intracarnial aneurysm minimum hight less than 4.0 mm\n  7. Target Intracranial aneurysm contains other devices\u002Fimplants (e.g., coils)\n  8. Stenosis of the target IA's parent vessel \\>50%\n  9. Known allergy to platinum, nickel, or titanium\n  10. Known allergy to contrast agents\n  11. Absolute contraindication to anticoagulation or antiplatelet therapy\n  12. Anticoagulation medications such as warfarin that cannot be discontinued\n  13. Pregnant, breastfeeding or planning pregnancy within next 12 months\n  14. Acute or chronic renal failure (stage III or IV by VARC-3 criteria)\n  15. Cerebral embolism, stroke, or TIA in past 6 months\n  16. Myocardial infarction in the past 6 months\n  17. Any other medical issue within the brain that would preclude device implantation (such as brain surgery, radiation in the target area of intervention from an external beam source, acute traumatic craniocerebral injury, etc.)\n  18. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.\n  19. Patient had physical, neurologic or psychiatric conditions which precluded his\u002Fher ability to comply with all aspects of the screening, evaluation, treatment, and the postprocedure follow-up schedule.\n  20. Other medical conditions that cause an inability to comply with study requirements and\u002For that could increase the risk of neurovascular procedures (e.g., extreme frailty, liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)\n  21. Patient had a life expectancy of less than 12 months .\n  22. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.",{"count":117,"type":21},30,[24],"The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.",[97,98,99,29,31],[98,122,123,124,125,126],"Embolization","Flow Diverter","Intrasaccular Device","Cerebral Aneurysm","Unruptured","2025-11-21",{"date":129,"type":45},"2025-11-26",{"date":131,"type":45},"2024-10-07",{"date":133,"type":21},"2027-06",{"name":108,"class":52},6,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":135},"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":145,"type":21},2000,[24],"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",[29,149,150],"Intracranial Aneurysm","Unruptured Cerebral Aneurysm",[99,152,153,154],"Endovascular treatment","Surgical treatment","Conservative management","2025-07-23",{"date":157,"type":45},"2025-07-28",{"date":159,"type":45},"2020-01-15",{"date":161,"type":21},"2036-01",{"name":163,"class":83},"Centre hospitalier de l'Université de Montréal (CHUM)"]