Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT01793792
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne.hurley@microvention.com', 'phone': '714-247-8000', 'title': 'Anne Hurley', 'organization': 'MicroVention, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Device: LVIS', 'description': 'LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 15, 'seriousNumAtRisk': 153, 'deathsNumAffected': 6, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection or perforation of the parent artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-Parenchymal Hemorrhage (IPH)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological deficits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stent Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-Arachnoid Hemorrhage (SAH)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sub-Dural Hematoma (SDH)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TIA (Transient Ischemic Attack)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Target aneurysm retreatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: LVIS', 'description': 'Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: LVIS', 'description': 'Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device: LVIS', 'description': 'Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '153 treated: 1 attempted no device implanted, 152 device implanted.', 'groupId': 'FG000', 'numSubjects': '153'}]}, {'type': 'Treated', 'achievements': [{'comment': '153 Treated, 152 implanted with device, 1 attempted no device implanted', 'groupId': 'FG000', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Device Not Implanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device: LVIS', 'description': 'LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '10.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Low Profile Visualized Intraluminal Support device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2018-03-20', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2013-02-14', 'dispFirstSubmitQcDate': '2018-03-21', 'resultsFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2013-02-14', 'dispFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"', 'timeFrame': '12 months'}, {'measure': 'Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['intracranial, saccular, aneurysms, stenting, coiling'], 'conditions': ['Intracranial Aneurysms']}, 'referencesModule': {'references': [{'pmid': '30297543', 'type': 'DERIVED', 'citation': 'Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.'}], 'seeAlsoLinks': [{'url': 'https://jnis.bmj.com/content/early/2018/10/15/neurintsurg-2018-014309', 'label': 'The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK on behalf of LVIS Investigators'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject age between 18 and 75 years\n* Subject with an unruptured or ruptured(\\>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio \\<2)intracranial saccular aneurysm (\\<20mm maximum diameter in any plane)\n\nExclusion Criteria:\n\n* Subject with significant extra or intracranial stenosis of the parent artery (\\>50%) proximal to the target aneurysm.\n* Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke\n* Subject with contraindications to the use of antiplatelet agents\n* Subject who is unable to complete the required follow-up'}, 'identificationModule': {'nctId': 'NCT01793792', 'acronym': 'LVIS', 'briefTitle': 'Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Microvention-Terumo, Inc.'}, 'officialTitle': 'Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS', 'orgStudyIdInfo': {'id': 'CL11002'}, 'secondaryIdInfos': [{'id': 'G110188/S004', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Device: LVIS', 'description': 'The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.\n\nDevice: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device', 'interventionNames': ['Device: LVIS™ and LVIS™ Jr']}], 'interventions': [{'name': 'LVIS™ and LVIS™ Jr', 'type': 'DEVICE', 'otherNames': ['Low Profile Visualized Intraluminal Support device'], 'description': 'The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.', 'armGroupLabels': ['Device: LVIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Dignity Health/Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Health and Hospital', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Methodist Research Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo Neurosurgery', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist University Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Fiorella, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Microvention-Terumo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}