Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-13 @ 5:57 AM
Study NCT ID:
NCT02309203
Status:
WITHDRAWN
Last Update Posted:
2015-07-28
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
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{'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study not initiated at our site.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death or major stroke', 'timeFrame': 'within 30 days post procedure', 'description': 'A major stroke is defined as a new neurological event that persists for \\> 24 hours and results in a mRS \\>2. A minor stroke is defined as a new neurological event that persists for \\> 24 hours.'}, {'measure': 'neurological death or major ipsilateral stroke, measured by mRS.', 'timeFrame': 'within 6 months post procedure'}], 'secondaryOutcomes': [{'measure': 'Incidence of FRED System and procedure related Serious Adverse Events;', 'timeFrame': '1 year'}, {'measure': 'Incidence of successful delivery of the FRED System implant;', 'timeFrame': '24 hours'}, {'measure': 'Incidence of migration of the FRED System implant', 'timeFrame': '6 months'}, {'measure': 'Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)', 'timeFrame': 'Within 6 months', 'description': 'Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject'}, {'measure': 'Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)', 'timeFrame': '6 months', 'description': 'as measured by an increase in the modified Rankin Scale compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject whose age is ≥ 18 years;\n* Subject has a single target aneurysm located in the following zones:\n* Zone 1 - Petrous through cavernous of the ICA\n* Zone 2 - Ophthalmic segment of the ICA\n* Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery\n* Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:\n* Aneurysms with a neck \\> 4mm, dome to neck ratio ≤2 or no discernible neck\n* Fusiform aneurysms of any size requiring treatment;\n* The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);\n* Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;\n* Negative pregnancy test in a female subject who has had menses in the last 24 months;\n* Subject is willing to return for the 1-month and 6-month follow-up evaluations\n\nExclusion Criteria:\n\n* Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;\n* Subject who suffers from any intracranial hemorrhage in the last 30 days;\n* Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;\n* Subject with stenosis of the parent artery (\\>50%) proximal to the target aneurysm;\n* Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;\n* Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);\n* Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry\n* Subject with documented contrast allergy, or other condition, that prohibits imaging.\n* Evidence of active bacterial infection at the time of treatment;\n* Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;\n* Subject with life-threatening diseases.'}, 'identificationModule': {'nctId': 'NCT02309203', 'acronym': 'CanFRED', 'briefTitle': 'Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial', 'orgStudyIdInfo': {'id': 'CE 14.295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flow Re-Direction Endoluminal Device', 'description': 'Flow Re-Direction Endoluminal Device (FRED Device)', 'interventionNames': ['Device: FRED']}], 'interventions': [{'name': 'FRED', 'type': 'DEVICE', 'description': 'Flow Re-Direction Endoluminal Device', 'armGroupLabels': ['Flow Re-Direction Endoluminal Device']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jean Raymond', 'investigatorAffiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}}}}