Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT06210633
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011216', 'term': 'Practice Management, Medical'}], 'ancestors': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 990}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-07', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale score', 'timeFrame': '90 days after enrollment', 'description': 'Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death'}], 'secondaryOutcomes': [{'measure': 'independent ambulation (defined as a mRS score of 0-3) at 90 days', 'timeFrame': '90 days after enrollment', 'description': 'Score of 0-3 on the modified Rankin scale'}, {'measure': 'Not requiring constant care or better (defined as a mRS score of 0-4) at 90 days', 'timeFrame': '90 days after enrollment', 'description': 'Score of 0-4 on the modified Rankin scale'}, {'measure': 'Functional independence', 'timeFrame': '90 days after enrollment', 'description': 'Score of 0-2 on the modified Rankin scale'}, {'measure': 'Excellent outcome', 'timeFrame': '90 days after enrollment', 'description': 'Score of 0-1 on the modified Rankin scale'}, {'measure': 'Incidence of symptomatic intracranial hemorrhage (SICH)', 'timeFrame': '48 hours after enrollment', 'description': 'using Heidelberg criteria to assess SICH'}, {'measure': 'Mortality', 'timeFrame': '90 days after enrollment', 'description': 'Death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': "Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \\[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\\], LASTE \\[LArge Stroke Therapy Evaluation\\], RESCUE-Japan LIMIT \\[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\\], SELECT 2 \\[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\\], and TENSION \\[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \\[ASPECTS\\] ≥3 or infarct core \\<100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical inclusion criteria:\n\n1. Acute ischemic stroke within 24 hours from onset to enrollment;\n2. The patient or patient's representative signs a written informed consent form;\n\n Imaging inclusion criteria:\n3. If the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery M1 or M2, or the anterior cerebral artery A1, the baseline ASPECTS is 0 to 2 based on NCCT, or cerebral infarction core volume ≥85ml based on CT perfusion.\n4. If the occlusion site is located in the vertebrobasilar artery, then the baseline pc-ASPECTS is 0 to 5.\n\nExclusion Criteria:\n\n1. CT or MR evidence of hemorrhage;\n2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;\n3. Currently pregnancy;\n4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;\n5. Any terminal illness with life expectancy less than 6 months."}, 'identificationModule': {'nctId': 'NCT06210633', 'acronym': 'XL-STROKE', 'briefTitle': 'Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Prospective Registry', 'orgStudyIdInfo': {'id': 'XL STROKE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular thrombectomy', 'description': 'Patients in this group will be treated with medical management plus endovascular thrombectomy', 'interventionNames': ['Other: medical management', 'Other: endovascular thrombectomy']}, {'label': 'Medical management', 'description': 'Patients in this group will be treated with medical management alone', 'interventionNames': ['Other: medical management']}], 'interventions': [{'name': 'medical management', 'type': 'OTHER', 'description': 'Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.', 'armGroupLabels': ['Endovascular thrombectomy', 'Medical management']}, {'name': 'endovascular thrombectomy', 'type': 'OTHER', 'description': 'Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.', 'armGroupLabels': ['Endovascular thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '421001', 'city': 'Xiangtan', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangxiong Yuan', 'role': 'CONTACT', 'email': 'yuanguangxiong74@163.com', 'phone': '18973223018'}], 'facility': 'Xiangtan Central Hospital', 'geoPoint': {'lat': 27.85, 'lon': 112.9}}], 'centralContacts': [{'name': 'Zhongming Qiu', 'role': 'CONTACT', 'email': 'qiuzhongmingdoctor@163.com', 'phone': '+8613236599269'}, {'name': 'Thanh N. Nguyen', 'role': 'CONTACT', 'email': 'thanh.nguyen@bmc.org'}], 'overallOfficials': [{'name': 'Guangxiong Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangtan Central Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '3 years after the trial results are revealed', 'ipdSharing': 'YES', 'description': 'Study Protocol, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.', 'accessCriteria': 'after approval of a proposal from principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongming Qiu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiangtan Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhongming Qiu', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}