Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 3:31 AM
Study NCT ID:
NCT01006993
Status:
COMPLETED
Last Update Posted:
2010-03-11
First Post:
2009-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-10', 'studyFirstSubmitDate': '2009-11-02', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.', 'timeFrame': 'Baseline to 30 days post-treatment'}], 'secondaryOutcomes': [{'measure': 'Potential patient benefit will be assessed through collection of neurological indices.', 'timeFrame': 'Baseline through 90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '21350210', 'type': 'DERIVED', 'citation': 'Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke\n* NIHSS between 5-22\n* Persistent clinical deficits following administration of rt-PA\n\nExclusion Criteria:\n\n* Planned thrombectomy\n* Aortic pathology\n* Severe heart disease\n* Other conditions the doctor will assess'}, 'identificationModule': {'nctId': 'NCT01006993', 'acronym': 'FASTFlo tPA', 'briefTitle': 'Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoAxia'}, 'officialTitle': 'Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA', 'orgStudyIdInfo': {'id': 'CD-0258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeuroFlo Treatment', 'interventionNames': ['Device: NeuroFlo catheter']}], 'interventions': [{'name': 'NeuroFlo catheter', 'type': 'DEVICE', 'description': 'NeuroFlo™ catheter 45 minute treatment', 'armGroupLabels': ['NeuroFlo Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5B 4A2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'FASTFlo Steering Committee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Various'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoAxia', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Lori Austin', 'oldOrganization': 'CoAxia, Inc.'}}}}