Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-01 @ 5:12 PM
Study NCT ID:
NCT02419794
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2420}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset', 'timeFrame': '72 hours'}, {'measure': 'Reccurrence of stroke within 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}], 'primaryOutcomes': [{'measure': 'modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Death within 90 days (+/- 10 day) after the onset', 'timeFrame': '90 days'}, {'measure': 'modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}, {'measure': 'All bleeding within 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}, {'measure': 'All intracranial hemorrhage within 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}, {'measure': 'Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '34284599', 'type': 'DERIVED', 'citation': 'Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Toyoda K, Sakai N, Yoshimura S. Endovascular Therapy for Acute Ischemic Stroke in Patients With Prestroke Disability. J Am Heart Assoc. 2021 Aug 3;10(15):e020783. doi: 10.1161/JAHA.121.020783. Epub 2021 Jul 21.'}, {'pmid': '33641385', 'type': 'DERIVED', 'citation': 'Fujita K, Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Imamura H, Sakai N, Ohara N, Matsumoto Y, Takeuchi M, Shigeta K, Toyoda K, Yoshimura S. Outcomes of Large Vessel Occlusion Stroke in Patients Aged >/=90 Years. Stroke. 2021 May;52(5):1561-1569. doi: 10.1161/STROKEAHA.120.031386. Epub 2021 Mar 1.'}, {'pmid': '32295504', 'type': 'DERIVED', 'citation': 'Saito T, Itabashi R, Yazawa Y, Uchida K, Yamagami H, Sakai N, Morimoto T, Yoshimura S; RESCUE-Japan Registry 2 Investigators. Clinical Outcome of Patients With Large Vessel Occlusion and Low National Institutes of Health Stroke Scale Scores: Subanalysis of the RESCUE-Japan Registry 2. Stroke. 2020 May;51(5):1458-1463. doi: 10.1161/STROKEAHA.119.028562. Epub 2020 Apr 16.'}, {'pmid': '29695384', 'type': 'DERIVED', 'citation': 'Yoshimura S, Sakai N, Uchida K, Yamagami H, Ezura M, Okada Y, Kitagawa K, Kimura K, Sasaki M, Tanahashi N, Toyoda K, Furui E, Matsumaru Y, Minematsu K, Morimoto T. Endovascular Therapy in Ischemic Stroke With Acute Large-Vessel Occlusion: Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism Japan Registry 2. J Am Heart Assoc. 2018 Apr 25;7(9):e008796. doi: 10.1161/JAHA.118.008796.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to clarify treatment status and clinical results of acute cerebral ischemia after approval of clot retriever in Japan, and also to obtain a basis for comparative studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute cerebral large vessel occlusion admitted within 24 hours after onset.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted from Oct. 1st 2014 to Sep. 30st 2016.\n* Patients who were 20 years and older admitted within 24 hours after onset.\n* The patients with large vessel occlusion (ICA, MCA, VA, BA, PCA).\n* Patients who did not fulfill the criteria of RESCUE-Japan RCT.\n\nExclusion Criteria:\n\n･Patients who are considered inappropriate to participate in the study are excluded.'}, 'identificationModule': {'nctId': 'NCT02419794', 'briefTitle': 'Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2', 'organization': {'class': 'OTHER', 'fullName': 'Hyogo Medical University'}, 'officialTitle': 'Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2', 'orgStudyIdInfo': {'id': 'UMIN000015273'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group with endovascular treatment', 'description': 'Group with additional endovascular treatment', 'interventionNames': ['Procedure: endovascular treatment']}, {'label': 'Group without endovascular treatment', 'description': 'Group without additional endovascular treatment'}], 'interventions': [{'name': 'endovascular treatment', 'type': 'PROCEDURE', 'description': 'endovascular treatment for acute ischemic stroke patients with large vessel occlusion', 'armGroupLabels': ['Group with endovascular treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '663-8501', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo College of Medicine', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}], 'overallOfficials': [{'name': 'Shinichi Yoshimura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hyogo Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyogo Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shinichi Yoshimura', 'investigatorAffiliation': 'Hyogo Medical University'}}}}