Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT01895634
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yikeda5@its.jnj.com', 'phone': '+81-3-4411-6789', 'title': 'Depertment Chief, Clinical Operation', 'organization': 'Johnson & Johnson K.K. Medical Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days post procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once', 'otherNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral vasoconstriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraoperative cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burns third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Who Have Recanalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'immediately post procedure', 'description': 'Proportion of subjects who had recanalization, TICI 2a or better', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subject Who Have Clot Migration/Embolization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'immediately post procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days post procedure', 'description': 'The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death", or similar, as accurate.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-hour post procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing value was not be imputed (1 missing subject was because of the death within 24 hours)'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days post-procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Intervention Device: Rev-01\n\nRev-01: Treatment arm patients have used Rev-01 at least once'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2013-07-01', 'resultsFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2013-07-05', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-06', 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Who Have Recanalization', 'timeFrame': 'immediately post procedure', 'description': 'Proportion of subjects who had recanalization, TICI 2a or better'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subject Who Have Clot Migration/Embolization', 'timeFrame': 'immediately post procedure'}, {'measure': 'Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure', 'timeFrame': '90 days post procedure', 'description': 'The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death", or similar, as accurate.'}, {'measure': 'Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)', 'timeFrame': '24-hour post procedure'}, {'measure': 'All Cause Mortality', 'timeFrame': '90 days post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischemia', 'Stroke', 'Ischemic Stroke', 'Thrombectomy', 'Brain clot', 'Cerebrovascular disease', 'Recanalization', 'Revascularization', 'Clot Retriever', 'Neurovascular Intervention', 'Interventional Neuroradiology', 'neurovascular clinical trial'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subject presenting with clinical signs and symptoms consistent with a diagnosis of acute ischemic stroke\n* Onset of symptom is within 8 hours prior to treatment with Rev-01\n* Treatment with IV t-PA is ineligible or ineffective\n* Occluded (presenting TICI score of 0 or 1) M1 or M2 of MCA, basilar or vertebral artery, or intracranial segment of ICA, confirmed by angiography that it is accessible to the Rev-01\n* NIHSS score is 8-30\n* Prior to new focal disabling neurologic deficit, mRS score was 0-2\n* Age from 20 y.o. to 85 y.o.\n* Written informed consent to participate by subject or legal representative\n\nKey Exclusion Criteria:\n\n* Subject presenting; ICA dissection, Angiitis, Arterial tortuosity that would prevent the device from reaching the target vessel, Arterial stenosis \\> 50% that would prevent the device from reaching the target vessel, Evidence of acute intracranial hemorrhage, Evidence of mass effect or intracranial tumor, Evidence of extended early ischemic changes\n* Subject with more than two major artery occluded\n* Known sensitivity or ineligible to radiographic agent, or metallic allergy\n* Administration of dabigatran or heparin within 48 hours preceding the onset of stroke and have an elevated APTT or PTT above twice of the normal range for the laboratory at presentation\n* Known bleeding diathesis of current use of oral anticoagulants (e.g., warfarin sodium) with International Normalized Ration (INR) \\> 3\n* Platelet count \\< 30,000/mm3\n* Glucose \\< 50 mg/dL\n* Severe sustained hypertension (SBP \\> 185mmHG or DBP \\> 110mmHG) refractory to pharmacological management\n* Life expectancy of less than 90 days\n* Pregnancy or females who are lactating\n* Current participation in an investigational drug or device study\n* Otherwise determined by investigator to be medically unsuitable for participation'}, 'identificationModule': {'nctId': 'NCT01895634', 'briefTitle': 'Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson K.K. Medical Company'}, 'officialTitle': 'Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)', 'orgStudyIdInfo': {'id': 'Rev-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Intervention Device: Rev-01', 'interventionNames': ['Device: Rev-01']}], 'interventions': [{'name': 'Rev-01', 'type': 'DEVICE', 'description': 'Treatment arm patients have used Rev-01 at least once', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650-0046', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Nobuyuki Sakai, M.D., D.M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kobe City Medical Center General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson K.K. Medical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}