Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 9:36 PM
Study NCT ID:
NCT04416659
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow Arrest Safety and Technical Success With Balloon Guide Catheters
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Evaluation', 'timeFrame': 'Hospital discharge or 7 days', 'description': 'Incidence of device-related adverse events'}, {'measure': 'Performance Evaluation', 'timeFrame': 'Completion of procedure', 'description': 'Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.', 'detailedDescription': 'This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms\n* Adult patient willing to provide Informed Consent\n* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6\n\nExclusion Criteria:\n\n* Posterior circulation stroke\n* Tandem occlusions\n* Cervical carotid stenosis\n* Participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT04416659', 'acronym': 'FAST-BGC', 'briefTitle': 'Flow Arrest Safety and Technical Success With Balloon Guide Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Neurovascular Clinical Affairs'}, 'officialTitle': 'Flow Arrest Safety and Technical Success With Balloon Guide Catheters', 'orgStudyIdInfo': {'id': '3002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neuro-vascular access', 'type': 'DEVICE', 'description': 'Adjunctive device providing a conduit for retrieval device during thrombectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "BNI (St. Joseph's Hospital-Dignity Health)", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80112', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish-RIACO', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'KUMC', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '37902', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ft Sanders Regional Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}], 'overallOfficials': [{'name': 'Biraj Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carilion Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Neurovascular Clinical Affairs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}