Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 10:26 AM
Study NCT ID:
NCT05213533
Status:
UNKNOWN
Last Update Posted:
2022-02-11
First Post:
2022-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kanagawa Intravenous and Endvascular Treatment Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2022-01-16', 'studyFirstSubmitQcDate': '2022-01-16', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin Scale', 'timeFrame': 'after 3 months', 'description': 'The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. This is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months following hospital discharge.\n\n0 The patient has no residual symptoms.\n\n1. The patient has no significant disability; able to carry out all pre-stroke activities.\n2. The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.\n3. The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.\n4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.\n5. The patient has severe disability; bedridden, incontinent, requires continuous care.\n6. The patient has expired.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute stroke, mechanical thrombectomy, intravenous tPA'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '40746094', 'type': 'DERIVED', 'citation': 'Ueda T, Hasegawa Y, Takeuchi M, Morimoto M, Yamamoto R, Tsuboi Y, Kaga Y, Ito H, Onodera H, Takaishi S, Tatsuno K, Usuki N, Yoshie T, Murata H, Yamano Y; K-NET Registry Investigators. Comparative analysis of outcome-associated factors following endovascular treatment for intracranial atherosclerotic disease and cardioembolism: A subanalysis of the K-NET registry. Interv Neuroradiol. 2025 Aug 1:15910199251361304. doi: 10.1177/15910199251361304. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.', 'detailedDescription': 'Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.\n\nThe primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Kanagawa prefecture in Japan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.\n\nExclusion Criteria:\n\nThere were no exclusion criteria. There are no upper or lower age limits for this study.'}, 'identificationModule': {'nctId': 'NCT05213533', 'acronym': 'K-NET', 'briefTitle': 'Kanagawa Intravenous and Endvascular Treatment Registry', 'organization': {'class': 'OTHER', 'fullName': 'St. Marianna University Toyoko Hospital'}, 'officialTitle': 'Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '3757'}}, 'contactsLocationsModule': {'locations': [{'zip': '211-0063', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St.Marianna University Toyoko Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}], 'overallOfficials': [{'name': 'Toshihiro Ueda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Marianna University Toyoko Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Marianna University Toyoko Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Strokology; Director, Stroke Center', 'investigatorFullName': 'Toshihiro Ueda, MD', 'investigatorAffiliation': 'St. Marianna University Toyoko Hospital'}}}}