Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-01 @ 1:14 PM
Study NCT ID:
NCT04129203
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Versi Retriever Approving Trial in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-01', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good clinical outcome', 'timeFrame': '90days after procedure', 'description': 'modified Rankin Score is 0-2'}], 'secondaryOutcomes': [{'measure': 'Successful recanalization', 'timeFrame': 'at 3 passes of device in the procedure', 'description': 'TICI 2b-3'}, {'measure': 'Successful recanalization', 'timeFrame': 'at end of procedure', 'description': 'TICI 2b-3'}, {'measure': 'Symptomatic and asymptomatic intracranial hemorrhage', 'timeFrame': 'at 24 hours after procedure', 'description': 'NIHSS 4 or more worsened'}, {'measure': 'Good clinical outcome 2', 'timeFrame': '90days after procedure', 'description': 'mRS 0-2 or NIHSS 10 or more improvement'}, {'measure': 'sever advers event', 'timeFrame': '90days after procedure', 'description': 'device or procedure related'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke'], 'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.', 'detailedDescription': 'This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.\n\n60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute onset neurological sympto m related to occluded vessel\n* within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis\n* contra-indication or failed to int ravenous rt-PA\n* accessible occlusion at ICA, MC A, VA, BA, PCA\n* 5-30 of NIHSS\n* 0-2 of mRS before onset\n* obtain documented informed co ntent\n\nExclusion Criteria:\n\n* following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain\n* occlude 2 major vessel territory\n* allege for contrast media,\n* abnormal PTT/APTT within 4 h ours intravenous heparin\n* hemorrhagic tendency or 3 or more INR with Warfarin administration\n* 30000cc or less of Platelet\n* 50mg/dL or less of blood sugar\n* uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic\n* 90days or less life expancy\n* pregnant or lactating\n* join another trial of medicine or medical device\n* ineligible for trial'}, 'identificationModule': {'nctId': 'NCT04129203', 'briefTitle': 'Versi Retriever Approving Trial in Japan', 'organization': {'class': 'OTHER', 'fullName': 'Kobe City General Hospital'}, 'officialTitle': 'Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan', 'orgStudyIdInfo': {'id': 'VS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial arm', 'description': 'Mechanical thrombectomy using Versi Retriever', 'interventionNames': ['Device: Versi Retriever thrombectomy']}], 'interventions': [{'name': 'Versi Retriever thrombectomy', 'type': 'DEVICE', 'description': 'Mechanical thrombectomy using Versi Retriever', 'armGroupLabels': ['Trial arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Nobuyuki Sakai, MD, DMSc', 'role': 'CONTACT', 'email': 'n.sakai@siren.ocn.ne.jp', 'phone': '81783024321', 'phoneExt': '080'}, {'name': 'Chiaki Sakai, MD PhD', 'role': 'CONTACT', 'email': 'chiakimk@cronos.ocn.ne.jp', 'phone': '81783024321'}, {'name': 'Yasushi Matsumoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuji Matsumaru, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shinichi Yoshimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'centralContacts': [{'name': 'Nobuyuki Sakai, MD DMSc', 'role': 'CONTACT', 'email': 'n.sakai@siren.ocn.ne.jp', 'phone': '81783024321', 'phoneExt': '080'}, {'name': 'Chiaki Sakai, MD PhD', 'role': 'CONTACT', 'email': 'chiakimk@cronos.ocn.ne.jp', 'phone': '81783024321'}], 'overallOfficials': [{'name': 'Nobuyuki Sakai, MD DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Kobe City Medical Center General Hospital'}]}, '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'}}}}