Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT05503212
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D014715', 'term': 'Vertebrobasilar Insufficiency'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], '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'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 682}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-month modified Rankin scale', 'timeFrame': '90 days', 'description': '3-month functional outcome, \\[range: 0-6, 0= no symptoms, 6=death\\]'}], 'secondaryOutcomes': [{'measure': 'Symptomatic intracerebral haemorrhage (sICH)', 'timeFrame': '7 days', 'description': 'Any hemorrhagic transformation temporally related to any worsening in neurological condition. \\[yes/no\\]'}, {'measure': 'EVT procedural complications', 'timeFrame': 'During EVT procedure or peri-procedural', 'description': 'Any complication attributed to the procedure (vessel perforation, vasospasm, dissection, Subarachnoid haemorrhage (SAH)/Intracerebral haemorrhage (ICH), device detachment/misplacement, embolization to new territory, access-site complications, early reocclusion, other)'}, {'measure': '24-hour NIHSS', 'timeFrame': '24 hours', 'description': 'NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. \\[0-42, 0= no deficit, 42=maximum stroke severity\\]'}, {'measure': 'Early neurological deterioration (ENDi)', 'timeFrame': '24 hours', 'description': 'Early neurological deterioration of ischemic origin (ENDi) is defined as an increase in National Institute of Health Stroke (NIHSS) score ≥ 4 points or death within 24 hours. \\[yes/no\\]'}, {'measure': 'Cerebrovascular ischemic recurrences', 'timeFrame': '90 days', 'description': 'Any ischemic stroke or transient ischemic attack recurrence \\[yes/no\\]'}, {'measure': '24h and 3month mortality', 'timeFrame': '24h and 90 days', 'description': 'Mortality at 24h and 3 months'}, {'measure': 'Vessel recanalisation on follow up-imaging', 'timeFrame': '48 hours', 'description': 'Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prognosis', 'Revascularization', 'Treatment'], 'conditions': ['Ischemic Stroke', 'Vertebral Artery Ischemia', 'Arterial Occlusive Diseases', 'Vertebrobasilar Insufficiency']}, 'descriptionModule': {'briefSummary': 'Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.\n\nIn the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke and concomitant isolated vertebral artery occlusion accounting for stroke symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Acute ischemic stroke limited to the posterior circulation\n* Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)\n* IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021\n* ≥ 18 years old\n\nExclusion criteria\n\n* Extension of the occlusion into the basilar artery\n* Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)\n* Previously known chronic occlusion of the any segment of the vertebral artery/arteries\n* Local ethical/legal conditions in participating center not fulfilled'}, 'identificationModule': {'nctId': 'NCT05503212', 'acronym': 'BRAVO', 'briefTitle': 'Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis', 'orgStudyIdInfo': {'id': 'Stroke-VAO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AIS and isolated VAO', 'description': 'Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO)', 'interventionNames': ['Other: Conservative treatment (CT)', 'Other: Intravenous thrombolysis (IVT)', 'Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)']}], 'interventions': [{'name': 'Conservative treatment (CT)', 'type': 'OTHER', 'description': 'Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy', 'armGroupLabels': ['AIS and isolated VAO']}, {'name': 'Intravenous thrombolysis (IVT)', 'type': 'OTHER', 'description': 'Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy', 'armGroupLabels': ['AIS and isolated VAO']}, {'name': 'Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)', 'type': 'OTHER', 'description': 'Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis', 'armGroupLabels': ['AIS and isolated VAO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Dr. med. Alexander Salerno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'St John of God Hospital, Vienna', 'class': 'OTHER'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Clinical Centre of Serbia', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, {'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, {'name': 'The Cooper Health System', 'class': 'OTHER'}, {'name': 'University Hospital Carl Gustav Carus', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'Hospital de Egas Moniz', 'class': 'OTHER'}, {'name': 'Neurocenter of Southern Switzerland', 'class': 'OTHER'}, {'name': 'Corewell Health West', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, {'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Researcher, Principal Investigator', 'investigatorFullName': 'Dr. med. Alexander Salerno, MD', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}