Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT06260969
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Thrombosis specimens；Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days', 'timeFrame': 'patients achieve a clinical prognosis of mRS 0-2 at 90 days', 'description': 'Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with a good prognosis early after treatment', 'timeFrame': '24 hours after thrombectomy', 'description': 'Decrease in NIHSS score ≥ 8 or NIHSS score of 0-2 in 24 (-2/+12) hours'}, {'measure': 'Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR', 'timeFrame': '24 hours after thrombectomy', 'description': 'Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR'}, {'measure': 'Vascular recanalization', 'timeFrame': 'Immediately after thrombectomy', 'description': 'Revascularisation assessed by DSA immediately after thrombectomy；Postoperative revascularisation assessed by CTA/MRA/DSA using Arterial Occlusive Lesion (AOL) grading at 24 (-2/+12) hours postoperatively；Application of bedside TCD for assessment of revascularisation'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Endovascular treatments', 'Acute ischemic stroke', 'Stroke etiology', 'Retrieved clots', 'Intracranial artery stenosis'], 'conditions': ['Large Vessel Occlusion', 'Intracranial Artery Occlusion With Cerebral Infarction', 'Endovascular Treatments', 'Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.', 'detailedDescription': 'The focus of this trial is to investigate the neuroprotective effects of endovascular hypothermia on the refractory disease of large vessel occlusion with underlying ICAS by performing different modes of endovascular interventions including stenting, balloon dilationand balloon dilation combined with stenting in patients who meet clinical and imaging criteria. The clinical prognosis of patients with different treatment modalities will be followed up to provide high quality clinical evidence to guide the interventional treatment of potential large vessel occlusions in ICAS. The main objectives of the study were to establish a prospective cohort of acute large vessel occlusions with potential ICAS treated with endovascular therapy based on the specific etiology of stroke with a high prevalence of intracranial atherosclerotic stenosis in the Chinese population; to explore the efficacy and safety of endovascular therapy for acute ischaemic stroke with potential ICAS; to investigate the use of different endovascular treatment modalities for acute ischaemic stroke with potential ICAS in the Chinese population; and to explore the neuroprotective effects of selective endovascular hypothermia on large vessel occlusions with potential ICAS. To explore the neuroprotective effect of selective endovascular hypothermia on large vessel occlusion in potential ICAS. To provide objective data and theoretical support for the choice of treatment for large vessel occlusion in underlying ICAS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute cerebral infarction with underlying intracranial artery stenosis receiving endovascular treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT scan to exclude intracranial haemorrhage；CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography showing occlusion of the distal intracranial carotid artery or the first segment of the middle cerebral artery；ELVO with a base ICAS of \\> 70%；Mechanical thrombectomy within 6h after symptom onset in ischemic stroke；NIHSS≥6；receiving endovascular treatments；informed consent form signed by the patient or their legal representatives.\n\nExclusion Criteria:\n\n* Hemorrhagic body, coagulation factor deficiency or oral anticoagulant therapy(INR \\> 3.0)；Baseline platelet count \\<50,000/µL；Baseline blood glucose \\<50mg/dL or \\>400mg/dL；Intractable hypertension(systolic blood pressure \\>220 mmHg or diastolic blood pressure \\>110 mmHg) that cannot be controlled by medication；Patients intubated without a NIHSS score assessed by a neurologist or emergency physician prior to intubation；Stroke attack with epilepsy affecting baseline NIHSS score；End-stage diseases leading to less than one year of expected survival for patients；Severe allergy to contrast media；Patients with renal insufficiency (blood creatinine ≥ 3 mg/dL)；Female patients who are pregnant or breastfeeding；The patient is participating in other drugs or device studies that may affect this study；Patient with cerebral vasculitis'}, 'identificationModule': {'nctId': 'NCT06260969', 'briefTitle': 'Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis: a Prospective, Multicentre Registry Study', 'orgStudyIdInfo': {'id': 'TJHH-2023-WM13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular therapy', 'description': 'Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting', 'interventionNames': ['Device: balloon dilatation']}], 'interventions': [{'name': 'balloon dilatation', 'type': 'DEVICE', 'otherNames': ['endovascular stenting', 'aspiration catheter', 'stent retriever', 'Tirofiban', 'intracranial stenting', 'normal saline'], 'description': 'Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting', 'armGroupLabels': ['Endovascular therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Wei', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}], 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ming Wei, PhD', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}], 'overallOfficials': [{'name': 'Ming Wei, doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Huanhu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Neurosurgery, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Ming Wei', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}