Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT05326932
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 382}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-22', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intracerebral hemorrhage (ICH)', 'timeFrame': '24 hours and 90 days', 'description': 'a) symptomatic ICH, based on previous criteria; b) ICH of any type in brain imaging'}, {'measure': 'Death', 'timeFrame': '7 days and 90 days', 'description': 'Death'}, {'measure': 'Serious adverse events (SAE)', 'timeFrame': '90 days', 'description': 'All SAE during follow-up in all randomized patients'}], 'primaryOutcomes': [{'measure': 'Functional recovery (level of disability)', 'timeFrame': '90 days', 'description': 'Shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Neurological impairment', 'timeFrame': '24 hours and 7 days', 'description': 'Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome.'}, {'measure': 'Death or major disability', 'timeFrame': '90 days', 'description': 'modified Rankin scale (mRS) 3-6'}, {'measure': 'Separately on death and disability', 'timeFrame': '90 days', 'description': 'modified Rankin scale (mRS) 3-5'}, {'measure': 'Health-related Quality of Life (HRQoL)', 'timeFrame': '90 days', 'description': 'using EQ-5D. European Quality of Life 5-dimensional questionnaire. The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: Higher scores mean a worse outcome.'}, {'measure': 'Utility-weighted modified Rankin scale scores', 'timeFrame': '90 days', 'description': 'Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.\n\nHigher scores mean a worse outcome.'}, {'measure': 'Duration of hospitalization', 'timeFrame': '90 days', 'description': 'Days of hospitalization'}, {'measure': 'Residence', 'timeFrame': '90 days', 'description': 'Days of residence'}, {'measure': 'Hospital service costs', 'timeFrame': '90 days', 'description': 'Health economic measurement'}, {'measure': 'Infarct volume on DWI, or CT', 'timeFrame': '24 hours', 'description': 'Infarct volume on DWI, or CT if DWI not feasible'}, {'measure': 'Recanalization', 'timeFrame': '24 hours after MT', 'description': 'Recanalization confirmed on imaging'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Large vessel occlusion', 'Mechanical thrombectomy', 'Extended time', 'Randomised clinical trial'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS', 'detailedDescription': 'The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size at 24-48 hours; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; residence; and hospital service costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Present 24-72 hours of stroke onset or last seen well\n3. Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging\n4. National Institute of Health stroke scale (NIHSS) ≥6 at randomisation\n5. Viable cerebral tissue on computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) assessed: infarct core volume \\<50mL, mismatch ratio ≥1.8 and mismatch volume ≥15mL\n6. Written informed consent (by patient or proxy, according to local requirements)\n\nExclusion Criteria:\n\nClinical Exclusion Criteria\n\n1. Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician\n2. Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)\n3. Pregnancy\n4. Unable to undergo a CTP or MRP\n5. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure\n6. Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined\n7. Baseline blood glucose of \\<50mg/dL (2.78 mmol/L) or \\>400mg/dL (22.20 mmol/L)\n8. Baseline platelet count \\<50,000/uL\n9. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) \\>3\n10. Severe, sustained hypertension (systolic blood pressure (BP) \\>220 mmHg or diastolic BP \\>120 mmHg)\n11. Presumed septic embolus, suspicion of bacterial endocarditis\n12. EVT attempted after stroke onset\n13. Unlikely to participate in follow-up assessments\n14. Currently participating in another trial that may affect outcomes.\n15. Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.\n\nNeuroimaging Exclusion Criteria\n\n1. Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination\n2. Evidence of intracranial tumor (except small meningioma)\n3. Significant mass effect with midline shift\n4. Aortic dissection\n5. Intracranial stent implanted in the same vascular territory\n6. Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover\n7. Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)'}, 'identificationModule': {'nctId': 'NCT05326932', 'acronym': 'LATE-MT', 'briefTitle': 'Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute for Global Health, China'}, 'officialTitle': 'An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion', 'orgStudyIdInfo': {'id': 'LATE-MT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Mechanical thrombectomy to be initiated as soon as possible after randomisation.', 'interventionNames': ['Procedure: Mechanical thrombectomy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.'}], 'interventions': [{'name': 'Mechanical thrombectomy', 'type': 'PROCEDURE', 'description': 'Subjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianmin Liu, MD', 'role': 'CONTACT'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lily Song, PhD', 'role': 'CONTACT', 'email': 'lsong@georgeinstitute.org.cn', 'phone': '+86 13916466400'}, {'name': 'Craig Anderson, PhD', 'role': 'CONTACT', 'email': 'canderson@georgeinstitute.org.au', 'phone': '+61 2 8052 4521'}], 'overallOfficials': [{'name': 'Craig Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute for Global Health, China'}, {'name': 'Jianmin Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'url': 'http://georgeinstitute.org.au', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data sharing will be available from 12 months after the publication of the main results.', 'ipdSharing': 'YES', 'description': 'Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.', 'accessCriteria': '1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.\n2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.\n3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.\n4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.\n5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute for Global Health, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}