Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 9:12 PM
Study NCT ID:
NCT04664933
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-06', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences in serum factors levels and blood gas in diverse vessel region', 'timeFrame': 'Hour 0', 'description': 'Differences in serum factors levels and blood gas in diverse vessel region'}, {'measure': 'Changes in serum factors levels', 'timeFrame': '30 minutes, 24 hours', 'description': 'changes in serum factors levels before and at different timepoints after recanalization'}], 'primaryOutcomes': [{'measure': 'Proportion of server adverse events', 'timeFrame': '48 hours', 'description': 'server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with modified Rankin Score 0 to 1', 'timeFrame': '90 days', 'description': 'Proportion of patients with modified Rankin Score 0 to 1'}, {'measure': 'Proportion of patients with modified Rankin Score 0 to 2', 'timeFrame': '90 days', 'description': 'Proportion of patients with modified Rankin Score 0 to 2'}, {'measure': 'Modified Rankin Score', 'timeFrame': '90 days', 'description': 'Modified Rankin Score'}, {'measure': 'Decrease in national institutes of health stroke scale (NIHSS)', 'timeFrame': '48 hours', 'description': 'Decrease in NIHSS scoring at 48 hours after the treatment'}, {'measure': 'Proportion of symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '48 hours', 'description': 'sICH was defined as 4 or more increase in NIHSS caused by hemorrhage'}, {'measure': 'Proportion of intraparenchymal hemorrhage (PH1 and PH2)', 'timeFrame': '48 hours', 'description': 'Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment'}, {'measure': 'Changes in cerebral edema', 'timeFrame': '48 hours', 'description': 'Cerebral edema was determined by cerebral volume or midline shift'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic', 'Intravascular Thrombosis', 'Mechanical Thrombectomy']}, 'descriptionModule': {'briefSummary': 'To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Acute ischemic stroke patients who is eligible for endovascular treatment;\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1. Modified Rankin Score \\>2 caused by a history of prior stroke;\n2. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\\<80000/mm3);\n3. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;\n4. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);\n5. Unsuitable for this clinical studies assessed by researcher.'}, 'identificationModule': {'nctId': 'NCT04664933', 'briefTitle': 'Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study', 'orgStudyIdInfo': {'id': 'K (2020) 32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-arterial administration of 3-n-butylphthalide', 'description': 'Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min.', 'interventionNames': ['Drug: Intra-arterial administration of neuroprotective agents']}], 'interventions': [{'name': 'Intra-arterial administration of neuroprotective agents', 'type': 'DRUG', 'description': 'Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min', 'armGroupLabels': ['Intra-arterial administration of 3-n-butylphthalide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui-Sheng Chen, Ph.D.', 'role': 'CONTACT', 'email': 'chszh@aliyun.com', 'phone': '+86 13352452086'}], 'facility': 'Department of Neurology, General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hui-Sheng Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}