Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 6:34 PM
Study NCT ID:
NCT06763458
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2024-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2025-01-01', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in cortical oxygen saturation', 'timeFrame': 'at 24±8 hours'}, {'measure': 'Changes of cerebral blood flow autoregulation function', 'timeFrame': 'at 24±8 hours'}], 'primaryOutcomes': [{'measure': 'Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)', 'timeFrame': 'at 24±8 hours'}], 'secondaryOutcomes': [{'measure': 'The decrease of NIHSS score', 'timeFrame': 'at 24±8 hours'}, {'measure': 'The decrease of NIHSS score', 'timeFrame': 'at 10±2 days'}, {'measure': 'Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)', 'timeFrame': 'at 24±8 hours'}, {'measure': 'Proportion of patients with modified Rankin Score 0 to 1', 'timeFrame': 'at 90±7 days'}, {'measure': 'Proportion of patients with modified Rankin Score 0 to 2', 'timeFrame': 'at 90±7 days'}, {'measure': 'Distribution of patients with modified Rankin Score', 'timeFrame': 'at 90±7 days'}, {'measure': 'the occurence of stroke or other cardiovascular events', 'timeFrame': 'at 90±7 days'}, {'measure': 'ischemic stroke in the culprit artery territory', 'timeFrame': 'at 90±7 days'}, {'measure': 'Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)', 'timeFrame': 'at 24±8 hours'}, {'measure': 'Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)', 'timeFrame': 'at 24±8 hours'}, {'measure': 'Proportion of serious adverse events', 'timeFrame': 'at 24±8 hours'}, {'measure': 'Proportion of all-cause deaths', 'timeFrame': 'at 10±2 days'}, {'measure': 'Complications associated with endovascular therapy', 'timeFrame': 'at 24±8 hours, at 10±2 days, at 90±7 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'Submaximal balloon angioplasty', 'early neurological deterioration', 'Intracranial atherosclerotic stenosis'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke, especially in East and South Asia, and is significantly associated with stroke recurrence and early neurological deterioration (END) despite aggressive medical management. Minor stroke (National Institutes of Health Stroke, NIHSS score ≤ 5) patients with ICAS often has higher risk of END. The early realization of blood flow patency is closely related to the improvement of patient outcomes. Submaximal balloon angioplasty (SBA) as a safer and simpler intervention which can improve cerebral blood flow. Thus, SBA may be an effective strategy for preventing END in acute ischemic stroke patients with ICAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 years of age;\n2. Minor ischemic stroke within 1 week of onset (NIHSS≤5);\n3. Have received the best drug treatment (dual antibody, anti-plate combined with anticoagulation), but symptoms still have measurable fluctuations or progression (NIHSS increased by at least 1 point);\n4. Symptoms fluctuate to the time of receiving balloon dilation within 24 hours;\n5. The etiology was considered to be severe stenosis of the responsible vessels due to intracranial arteriosclerosis (70-99% stenosis), or perforator artery disease with severe stenosis of the carrier artery (confirmed by MRA, CTA or DSA);\n6. Patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points;\n7. Patients or family members sign informed consent.\n\nExclusion Criteria:\n\n1. Patients who have developed large intracranial vessel occlusion;\n2. Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.;\n3. Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc.\n4. Clotting disorders or systemic bleeding tendency or platelets less than 100,000;\n5. Complicated with serious infection or liver, kidney and other serious diseases;\n6. Patients with severe inability to control hypertension (systolic blood pressure \\>200mmHg or diastolic blood pressure \\>110mmHg);\n7. Women who are pregnant, have a pregnancy plan or are breastfeeding;\n8. Complicated with other serious diseases, life expectancy \\< 6 months; Other conditions deemed inappropriate for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06763458', 'acronym': 'BAMUS-ICAS', 'briefTitle': 'Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study', 'orgStudyIdInfo': {'id': 'Y(2024)262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBA group', 'description': 'Receiving SBA plus best medical therapy', 'interventionNames': ['Procedure: Submaximal balloon angioplasty']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Receiving best medical therapy'}], 'interventions': [{'name': 'Submaximal balloon angioplasty', 'type': 'PROCEDURE', 'description': 'The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.', 'armGroupLabels': ['SBA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zi-Ai Zhao', 'role': 'CONTACT', 'email': 'zhaoziai@hotmail.com', 'phone': '+862428897491'}], 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Hui-Sheng Chen', 'role': 'CONTACT', 'email': 'chszh@aliyun.com', 'phone': '+86-024-28897511'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}