Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02609867
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'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': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': '5days', 'description': 'Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death.'}, {'measure': '≥50% intracranial aneurysm size reduction success at 6 month', 'timeFrame': '6months', 'description': 'Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).'}, {'measure': 'Aneurysm occlusion success at 6month', 'timeFrame': '6months', 'description': 'Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ'}], 'secondaryOutcomes': [{'measure': '≥50% Parent artery stenosis or occlusion', 'timeFrame': '6months'}, {'measure': 'Newly developed neurological disorder', 'timeFrame': '6months', 'description': 'Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS).'}, {'measure': 'Ipsilateral stroke', 'timeFrame': '6months', 'description': 'Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).'}, {'measure': '30-day death', 'timeFrame': '6months', 'description': '30-day death was defined as death within 30 days post procedure.'}, {'measure': 'Other adverse events', 'timeFrame': '6months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.", 'detailedDescription': 'Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functional neurological state ≤2 mRS\n* Unruptured wide-neck aneurysm in the internal carotid artery has a size \\>8mm, a neck ≥4mm, or dome/neck ratio \\<2\n* Parent artery with diameter ≥3.25mm and ≤4.5mm\n* Patient willing to provide written informed consent and comply with follow-up requirements\n\nExclusion Criteria:\n\n* Intracranial hemorrhage within 30 days\n* Untreated ruptured intracranial aneurysm\n* ≥1 intracranial aneurysm except the target one requires treatment within 6 months\n* Immunosuppressive disease\n* Active infectious disease (e.g. endocarditis, meningitis)\n* Platelet count \\< 100 x 103 cells/mm3\n* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.'}, 'identificationModule': {'nctId': 'NCT02609867', 'briefTitle': 'A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': "A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery", 'orgStudyIdInfo': {'id': 'FDV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flowise Cerebral Flow Diverter', 'description': 'Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)', 'interventionNames': ['Device: Flowise Cerebral Flow Diverter']}], 'interventions': [{'name': 'Flowise Cerebral Flow Diverter', 'type': 'DEVICE', 'description': 'Flowise Cerebral Flow Diverter Placement', 'armGroupLabels': ['Flowise Cerebral Flow Diverter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'state': 'Yeonsei-ro Seodaemun-gu', 'country': 'South Korea', 'facility': 'Yonsei University Healthcare System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Buyng Moon Kim, PhD. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University Healthcare System, Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}