Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 10:48 AM
Study NCT ID:
NCT06140550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-20
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ratio of control group to test group 1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month target lesion restenosis rate', 'timeFrame': '6-month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracranial balloon', 'stenosis'], 'conditions': ['Intracranial Atherosclerotic Stenosis']}, 'descriptionModule': {'briefSummary': 'This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years old;\n* Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70\\~99%(WASID method);\n\nExclusion Criteria:\n\n* Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;\n* Ischemic cerebral infarction occurred 3 weeks before surgery;\n* Cerebral hemorrhage 3 months before operation;'}, 'identificationModule': {'nctId': 'NCT06140550', 'briefTitle': 'Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bochang'}, 'officialTitle': 'Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis', 'orgStudyIdInfo': {'id': 'TP-NS-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Device: Drug balloon dilated']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'interventionNames': ['Device: balloon dilated']}], 'interventions': [{'name': 'Drug balloon dilated', 'type': 'DEVICE', 'description': 'Through the expansion after the balloon is in place,Release drugs on the surface of the balloon and improve the blood perfusion of nerve vessels to treat stenosis', 'armGroupLabels': ['Experimental group']}, {'name': 'balloon dilated', 'type': 'DEVICE', 'description': 'Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.', 'armGroupLabels': ['Control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bochang', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'Jinan Central Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'Beijing Geriatric Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}