Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-04 @ 8:31 AM
Study NCT ID:
NCT06683118
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-12
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-07-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion restenosis rate at 6 month postoperative', 'timeFrame': '180±30days', 'description': 'The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.'}], 'secondaryOutcomes': [{'measure': 'Technical succeed rate', 'timeFrame': 'Intraoperation', 'description': 'defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction'}, {'measure': 'Target vascular-related stroke or death at 30 days postoperatively', 'timeFrame': '30±7days'}, {'measure': 'Any stroke or death at 30 days postoperatively', 'timeFrame': '30±7days'}, {'measure': 'Target vascular-related stroke or death at 6 month postoperatively', 'timeFrame': '180±30days'}, {'measure': 'Any stroke or death at 6 month postoperatively', 'timeFrame': '180±30days'}, {'measure': 'Target vascular-related stroke or death at 12 month postoperatively', 'timeFrame': '360±60days'}, {'measure': 'Any stroke or death at 12 month postoperatively', 'timeFrame': '360±60days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Atherosclerotic Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Incsion Criteria:\n\n* Age 18 to 80 years old at informed consent signing.\n* Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis.\n* Medication ineffective.\n* modified Rankin Scale(mRS) score≤2.\n* The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.\n\nExclusion Criteria:\n\n* History of acute ischemic stroke within 2 weeks;\n* Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;\n* Target vessels complete occlusion or with thrombus in target vessels;\n* Target vessel with severe calcification or distortion that making interventional device is difficult to place;\n* History of stenting in the target artery;\n* Target vessel restenosis following stenting or balloon angioplasty;\n* Combined with other lesion with ≥70% stenosis in target vessel.\n* Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.\n* Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.\n* History of intracranial hemorrhage within 90days.\n* Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;\n* Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;\n* Allergic to contrast agents or rapamycin;\n* Pregnant or lactating women;\n* Participating or intending to participate in any other drug/device clinical trials;\n* Life expectancy \\<1 year;\n* Any other conditions that the investigator deems the patient unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT06683118', 'briefTitle': 'Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort NeuroTech Co., Ltd.'}, 'officialTitle': 'A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS', 'orgStudyIdInfo': {'id': 'JUJI-2023-01-CIP-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Device: Rapamycin neurovascular Balloon Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Device: Conventional Balloon']}], 'interventions': [{'name': 'Rapamycin neurovascular Balloon Catheter', 'type': 'DEVICE', 'description': 'Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis', 'armGroupLabels': ['experimental group']}, {'name': 'Conventional Balloon', 'type': 'DEVICE', 'description': 'Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Tiantan Hospital Affiliated of Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Affiliated of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort NeuroTech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}