Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03366818
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2017-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Stent Retriever, VERSI System for AIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017131', 'term': 'Thrombectomy'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2017-11-11', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of treatment-related severe adverse event', 'timeFrame': 'within 24 hours after procedure', 'description': 'symptomatic intracranial hemorrhage'}], 'secondaryOutcomes': [{'measure': 'recovery to independent life {modified Rankin score of 2 or less]', 'timeFrame': '90days after procedure', 'description': 'Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less'}, {'measure': 'all intracralnial hemorrhage', 'timeFrame': 'within 24 hours after procedure', 'description': 'incidence of symptomatic and asymptomatic intracranial hemorrhage'}, {'measure': 'acceptable clinical outcome', 'timeFrame': '90days after procedure', 'description': 'Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS'}, {'measure': 'Severe adverse event related to device', 'timeFrame': 'within 24 hours after procedure', 'description': 'Any severe adverse event related to device'}, {'measure': 'recanalization ability of device', 'timeFrame': 'immediatry after procedure', 'description': 'rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '30262657', 'type': 'DERIVED', 'citation': 'Sakai N, Imamura H, Adachi H, Tani S, Tokunaga S, Funatsu T, Suzuki K, Adachi H, Sasaki N, Kawabata S, Akiyama R, Horiuchi K, Ohara N, Kono T, Fujiwara S, Kaneko N, Tateshima S. First-in-man experience of the Versi Retriever in acute ischemic stroke. J Neurointerv Surg. 2019 Mar;11(3):296-299. doi: 10.1136/neurintsurg-2018-014040. Epub 2018 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'To confirm efficacy and safety of VERSI system for acute ischemic stroke', 'detailedDescription': 'Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* onset to treat within 8 hours\n* NIHSS 8 or more\n* ASPECTS 5 or more\n* Target vessel is ICA, MCA, VA, BA, PCA\n* non-eligible or failed IV rt-PA\n\nExclusion Criteria:\n\n* known hemorrhagic tendency\n* arterial dissection, vasculitis\n* allergy for contrast media\n* other inappropriate condition'}, 'identificationModule': {'nctId': 'NCT03366818', 'briefTitle': 'New Stent Retriever, VERSI System for AIS', 'organization': {'class': 'OTHER', 'fullName': 'Kobe City General Hospital'}, 'officialTitle': 'Efficacy and Safety of VERSI System for Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'NEURO0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thrombectomy', 'description': 'thrombectomy by Versi system', 'interventionNames': ['Device: thrombectomy']}], 'interventions': [{'name': 'thrombectomy', 'type': 'DEVICE', 'description': 'mechanical thrombectomy', 'armGroupLabels': ['thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Nobuyuki Sakai, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kobe City Medical Center General Hospital, Kobe, Japan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kobe City General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Neurosurgery', 'investigatorFullName': 'Nobuyuki Sakai', 'investigatorAffiliation': 'Kobe City General Hospital'}}}}