[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05453240":3,"trial-entities:NCT05453240":81,"trial-summary:NCT05453240":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":64,"locations":67,"central_contacts":77,"overall_officials":78,"references":79,"see_also_links":80},"NCT05453240","CL11008","Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device","Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device","ENROLLING_BY_INVITATION","2026-01-01","2025-06","2025-06-17","2020-11-17","Microvention-Terumo, Inc.","INDUSTRY",false,"The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.",null,[19],"Intracranial Aneurysms",[],"OBSERVATIONAL",[],{"count":24,"type":25},250,"ESTIMATED",[],[28,32,35,37,39,41,44,46,49],{"measure":29,"description":30,"timeFrame":31},"Complete or Stable Raymond Roy II","The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. It is also known as the Raymond class, Montreal scale or the Raymond Montreal scale","5 year",{"measure":33,"description":34,"timeFrame":31},"Intracranial hemorrhage including SAH and IPH","Determined by adverse event adjudication by the clinical events committee",{"measure":36,"description":34,"timeFrame":31},"All ischemic and hemorrhagic stroke",{"measure":38,"description":34,"timeFrame":31},"Neurological deaths",{"measure":40,"description":34,"timeFrame":31},"Transient Ischemic Attack",{"measure":42,"description":43,"timeFrame":31},"Parent artery patency","Determined by the corelab adjudication of images",{"measure":45,"description":43,"timeFrame":31},"In-stent stenosis",{"measure":47,"description":48,"timeFrame":31},"Target aneurysm retreatment","Presented by the subject medical records",{"measure":50,"description":48,"timeFrame":31},"Cerebral vasospasm",[],"ALL","18 Years",{"inclusion":55,"exclusion":61,"raw_text":63},[56,57,58,59,60],"Subjects treated with the LVIS® Device in accordance with currently approved indications for use;","Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \\\u003C 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.","Availability of Medical Health Records;","Subject whose age is ≥ 18;","Appropriate or Waived Consent:",[62],"Subjects not treated according to the currently approved indications for use","Inclusion Criteria:\n\nThe following criteria match the FDA-approved indications for use per PMA (P170013)\n\n* Subjects treated with the LVIS® Device in accordance with currently approved indications for use;\n* Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \\\u003C 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.\n\n(Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);\n\n* Availability of Medical Health Records;\n* Subject whose age is ≥ 18;\n* Appropriate or Waived Consent:\n\n  1. For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up;\n  2. For prospective follow up: Subject or his\u002Fher Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;.\n\nExclusion Criteria:\n\n* Subjects not treated according to the currently approved indications for use",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Microvention","Aliso Viejo","California","92656","United States",{"lat":75,"lon":76},33.56504,-117.72712,[],[],[],[],{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Intracranial Aneurysm",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]