Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-26 @ 10:22 AM
Study NCT ID:
NCT06510634
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-28
First Post:
2024-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion
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': 'ESTIMATED', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-07-14', 'studyFirstSubmitQcDate': '2024-07-14', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days', 'timeFrame': '90(±14)days', 'description': 'A 0-6 scale running from perfect health without symptoms to death.'}], 'secondaryOutcomes': [{'measure': 'distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days', 'timeFrame': '90(±14)days', 'description': 'A 0-6 scale running from perfect health without symptoms to death.'}, {'measure': 'Mortality within 90 days', 'timeFrame': '90(±14)days', 'description': 'mortality of any causes.'}, {'measure': 'Incidence of symptomatic intracranial haemorrhage', 'timeFrame': '90(±14)days', 'description': 'Symptomatic intracranial hemorrhage was characterized as any type of intracranial hemorrhage observed on follow-up imaging between 22 and 36 hours and 7 days after stroke onset, accompanied by an increase of at least 4 points on the NIHSS from baseline or the lowest value within 7 days, or resulting in mortality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a prospective, multicenter cohort study, which analyzed the prospectively databases of 11 stroke centers.Including patients with ischemic stroke due to vertebrobasilar artery beyond 24 hours from last known well.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age≥18 years.;\n2. blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);\n3. VBAO occurrence more than 24 hours from LKW;\n4. none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;\n5. informed consent before enrollment in the clinical trials.\n\nExclusion Criteria:\n\n1. neuroimaging evidence of cerebral hemorrhage on presentation;\n2. lack of follow up information on outcomes at 90 days\n3. serious, advanced, or terminal illness.'}, 'identificationModule': {'nctId': 'NCT06510634', 'acronym': 'VBAO-LATE', 'briefTitle': 'Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'Effectiveness and Safety of Endovascular Treatment vs. Best Medical Treatment in Patients With Vertebrobasilar Artery Occlusion Presenting Beyond 24 Hours of Last Known Well：a Prospective, Multicenter Registry Study', 'orgStudyIdInfo': {'id': 'TJHH-2024-WM51'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endovascular thrombectomy group', 'description': 'The EVT group would include Stent retriever thrombectomy; Aspiration; Balloon angioplasty and/or stenting; Intra-arterial medication; Combination', 'interventionNames': ['Other: Endovascular Therapy']}, {'label': 'best medical treatment gruop', 'description': 'BMM consisted of IVT antiplatelet drugs, anticoagulation, or combinations of these treatment modalities according to institutional guidelines.', 'interventionNames': ['Other: Endovascular Therapy']}], 'interventions': [{'name': 'Endovascular Therapy', 'type': 'OTHER', 'description': 'Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging.\n\nEndovascular therapy includes any one or more of the following:\n\nIntra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.', 'armGroupLabels': ['best medical treatment gruop', 'endovascular thrombectomy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ming Wei', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}