Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 4:27 AM
Study NCT ID:
NCT07345702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core Infarct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 518}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Achieving mRS 0-3 at 90 Days', 'timeFrame': '90 days', 'description': 'The modified Rankin scale (range, 0 \\[no symptoms\\] to 6 \\[death\\]). Higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Ordinal Shift analysis of mRS at 90 days', 'timeFrame': '90 days', 'description': 'The modified Rankin scale (range, 0 \\[no symptoms\\] to 6 \\[death\\])'}, {'measure': 'Rate of All-Cause Mortality at 90 Days', 'timeFrame': '90 days', 'description': 'Death from any cause within 90 days.'}, {'measure': 'Rate of Symptomatic Intracranial Hemorrhage', 'timeFrame': '24 (-2/+12) hours'}, {'measure': 'Proportion of Patients Achieving mRS 0-3 at 1 year', 'timeFrame': '1 year', 'description': 'The modified Rankin scale (range, 0 \\[no symptoms\\] to 6 \\[death\\]). Higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Basilar Artery Occlusion', 'Ischemic Stroke', 'Large Core Infarct']}, 'descriptionModule': {'briefSummary': 'This multicenter retrospective registry study evaluates the safety and effectiveness of endovascular therapy versus medical therapy for acute large-core basilar artery occlusion. It also investigates clinical, imaging, and laboratory factors associated with functional outcomes and mortality. Patients are grouped according to the treatment received in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (≥18 years) with imaging-confirmed acute vertebrobasilar occlusion and large-core infarction (pc-ASPECTS 0-5) treated within 7 days of symptom onset/last known well at participating centers in China. Patients are identified retrospectively from routine clinical practice and classified according to treatment received: endovascular therapy plus standard medical management versus standard medical management alone.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years, men or women.\n2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.\n3. Time from symptom onset (or last known well) to treatment (endovascular therapy or medical therapy) ≤7 days.\n4. Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 0-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.\n\nExclusion Criteria:\n\n1. Subjects with occlusions in both anterior and posterior circulation.\n2. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).\n3. Missing key clinical information (e.g., unavailable baseline NIHSS, unclear symptom onset/last known well time, or missing major treatment information including whether EVT was performed).\n4. Baseline NIHSS score \\<6.\n5. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.\n6. Missing follow-up outcomes at 90 days.\n7. Any other condition judged by investigators to substantially affect analysis or interpretation.'}, 'identificationModule': {'nctId': 'NCT07345702', 'acronym': 'BAOCHE-LC', 'briefTitle': 'Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core Infarct', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Endovascular Versus Medical Therapy for Acute Large-Core Basilar Artery Occlusion: A Multicenter Retrospective Registry Study (BAOCHE-LC)', 'orgStudyIdInfo': {'id': 'BAOCHE-LC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular Therapy', 'interventionNames': ['Procedure: Endovascular Therapy']}, {'label': 'Best Medical Treatment Alone'}], 'interventions': [{'name': 'Endovascular Therapy', 'type': 'PROCEDURE', 'description': "Endovascular therapy performed as part of routine clinical care for acute basilar artery occlusion, including mechanical thrombectomy with stent retriever and/or aspiration. Rescue angioplasty and/or intracranial stenting may be used at the operator's discretion. Peri-procedural management and concomitant medical therapy follow local standard practice.", 'armGroupLabels': ['Endovascular Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Chuanhui Li', 'role': 'CONTACT', 'email': 'lichuanhui@xwh.ccmu.edu.cn', 'phone': '15210439828'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Chuanhui Li', 'role': 'CONTACT', 'email': 'lichuanhui@xwh.ccmu.edu.cn', 'phone': '15210439828'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study is proceeding.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Xuanwu Hospital, Captimal Medical University', 'investigatorFullName': 'Chuanhui Li', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}