Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06365294
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rescue Extracranial Vertebral Stenting in Tandem Occlusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D014715', 'term': 'Vertebrobasilar Insufficiency'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The good 3-month outcome rate', 'timeFrame': '3 months', 'description': 'The good 3-month outcome rate was accessed by modified Rankin Score (mRS ≤ 2).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tandem occlusions', 'posterior circulation', 'rescue extracrnial stenting'], 'conditions': ['Acute Stroke', 'Ischemic Stroke, Acute', 'Vertebro Basilar Ischemia']}, 'referencesModule': {'references': [{'pmid': '27522497', 'type': 'BACKGROUND', 'citation': 'Cohen JE, Leker RR, Gomori JM, Eichel R, Rajz G, Moscovici S, Itshayek E. Emergent revascularization of acute tandem vertebrobasilar occlusions: Endovascular approaches and technical considerations-Confirming the role of vertebral artery ostium stenosis as a cause of vertebrobasilar stroke. J Clin Neurosci. 2016 Dec;34:70-76. doi: 10.1016/j.jocn.2016.05.005. Epub 2016 Aug 10.'}, {'pmid': '38277540', 'type': 'BACKGROUND', 'citation': 'Han N, Ma L, Zhao L, Xu G, Jia Y, Wang H. The Dilator-Dotter technique can successfully treat tandem lesions of posterior circulation. Medicine (Baltimore). 2024 Jan 26;103(4):e37044. doi: 10.1097/MD.0000000000037044.'}]}, 'descriptionModule': {'briefSummary': 'The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure', 'detailedDescription': 'Acute vertebrobasilar artery occlusion is one of the cerebrovascular diseases with high disability and mortality rates. Although mechanical thrombectomy has recently been demonstrated an effective treatment for large vessel occlusions of posterior circulation, the treatment strategies depending on the specific pathophysiology. Tandem occlusion in posterior circulation is less frequently than in anterior one, comprises severe stenosis or occlusion of the extracranial vertebral artery ipsilateral to its intracranial and basilar occlusion. The recent studies showed the benefit of the "distal-to-proximal" approach, there were many tecniques to achieved the successful recanalization. Besides, the use of Dotter technique allowed 8F guiding catheter to cross the extracranial lesions easily and save the procedural time. However, the Diagnosis 5F-Dotter, like the Dilator-Dotter, has not been mentioned in previous studies. Therefore, the aim of the our study was to assess the improvement of outcomes at 3 months posttreatment in patients receiving rescue extracranial vertebral stenting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Onset to treatment time \\< 24 hours\n* NIHSS \\> 5\n* pc-ASPECTS ≥ 5\n\nExclusion Criteria:\n\n* Premorbid mRS \\> 2\n* Extensive, bilateral brain-stem infarction on neuroimaging\n* Cerebellar mass effect on neuroimaging\n* Loss to follow-up'}, 'identificationModule': {'nctId': 'NCT06365294', 'acronym': 'REVET', 'briefTitle': 'Rescue Extracranial Vertebral Stenting in Tandem Occlusions', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho Stroke International Services Hospital'}, 'officialTitle': 'Rescue Extracranial Vertebral Stenting in Tandem Occlusions', 'orgStudyIdInfo': {'id': 'REVET Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rescue extracranial vertebral stenting', 'description': 'Rescue extracranial vertebral stenting in tandem occlusions', 'interventionNames': ['Procedure: Rescue extracranial stenting']}], 'interventions': [{'name': 'Rescue extracranial stenting', 'type': 'PROCEDURE', 'description': 'Rescue extracranial stenting in tandem occlusions', 'armGroupLabels': ['Rescue extracranial vertebral stenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900000', 'city': 'Can Tho', 'country': 'Vietnam', 'facility': 'Can Tho SIS Hospital', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}], 'overallOfficials': [{'name': 'Can Tho Stroke International Services Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Can Tho Stroke International Services General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Cuong Tran Chi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director - Doctor', 'investigatorFullName': 'Dr. Cuong Tran Chi', 'investigatorAffiliation': 'Can Tho Stroke International Services Hospital'}}}}