Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06120218
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The favorable 3-month outcome rate', 'timeFrame': '3 months', 'description': 'The favorable 3-month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).'}], 'secondaryOutcomes': [{'measure': 'The symptomatic intracerebral hemorrhage rate', 'timeFrame': '24 hours after emergent stenting', 'description': "The symptomatic intracerebral hemorrhage was defined as patient's intracerebral hemorrhage with postprocedural mRS ≥ 5 and there were no other evident causes for the increased modified Rankin Score (mRS)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombectomy', 'Extracranial arteries', 'Endovascular treatment', 'Antegrade approach', 'Retrograde approach'], 'conditions': ['Acute Stroke', 'Ischemic Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '36542074', 'type': 'BACKGROUND', 'citation': 'Allard J, Delvoye F, Pop R, Labreuche J, Maier B, Marnat G, Sibon I, Zhu F, Lapergue B, Consoli A, Spelle L, Denier C, Richard S, Piotin M, Gory B, Mazighi M; ETIS Investigators. 24-Hour Carotid Stent Patency and Outcomes After Endovascular Therapy: A Multicenter Study. Stroke. 2023 Jan;54(1):124-131. doi: 10.1161/STROKEAHA.122.039797. Epub 2022 Dec 21.'}, {'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': 'In acute ischemic stroke due to tandem occlusion, the emergent stenting has recently become an endovascular treatment option combining with mechanical thrombectomy to achieve recanalization. However, the data on the beneficial endovascular management of tandem occlusion in two circulations is still limited. The purpose of our study was to compare the improvement of clinical outcome between two circulations after emergent stenting at 3 months.', 'detailedDescription': 'The posterior circulation (about 20 - 25%) is less frequent than the anterior one in the acute ischemic stroke, but high mortality and morbidity in the acute vertebrobasilar thrombosis even successful recanalization are revealed. Besides, tandem occlusion is one of the complex lesions in large vessel occlusions relating to the poor outcome, particularly in the posterior circulation. Recent studies have suggested that emergent stenting could be used as an additional treatment to achieve permanent recanalization together with mechanical thrombectomy in the intracranial segments. Permanent recanalization is one of the most important factors that impact patient outcomes after acute ischemic stroke. However, although there are various approaches for this lesion, the comparision of the effectiveness in the two circulations remains unclear. Thus, the aims of our study were to compare baseline characteristics and clinical outcome of tandem occlusions between anterior and posterior circulation after emergent stenting in extracranial arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Premorbid mRS \\< 2\n* NIHSS \\> 5\n* ASPECTS ≥ 5 or pc-ASPECTS ≥ 5\n\nExclusion Criteria:\n\n* Onset to treatment time \\> 24 hours\n* Loss to follow up after discharge'}, 'identificationModule': {'nctId': 'NCT06120218', 'acronym': 'TOESIS', 'briefTitle': 'Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho Stroke International Services Hospital'}, 'officialTitle': 'Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke: Preliminary Experience From a Vietnamese Comprehensive Stroke Centre', 'orgStudyIdInfo': {'id': 'TOESIS Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emergent Stenting in Anterior circulation', 'description': 'Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions', 'interventionNames': ['Procedure: Emergent Stenting']}, {'type': 'EXPERIMENTAL', 'label': 'Emergent Stenting in Posterior circulation', 'description': 'Emergent Extracranial Vertebral Stenting in acute ischemic stroke caused by tandem occlusions', 'interventionNames': ['Procedure: Emergent Stenting']}], 'interventions': [{'name': 'Emergent Stenting', 'type': 'PROCEDURE', 'description': 'Emergent Stenting in acute ischemic stroke caused by tandem occlusions', 'armGroupLabels': ['Emergent Stenting in Anterior circulation', 'Emergent Stenting in Posterior circulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900000', 'city': 'Can Tho', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Cuong Tran Chi, Doctor', 'role': 'CONTACT', 'email': 'drcuongtran@dotquy.vn', 'phone': '+84886559911'}], 'facility': 'Can Tho Stroke International Services Hospital', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}], 'centralContacts': [{'name': 'Cuong Tran Chi, Doctor', 'role': 'CONTACT', 'email': 'drcuongtran@dotquy.vn', 'phone': '+84886559911'}, {'name': 'Can Tho Stroke International Services Hospital', 'role': 'CONTACT', 'email': 'cskh@dotquy.vn', 'phone': '+84886559911'}], 'overallOfficials': [{'name': 'Cuong Tran Chi, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Can Tho Stroke International Services General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can Tho Stroke International Services Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dr. Cuong Tran Chi', 'investigatorAffiliation': 'Can Tho Stroke International Services Hospital'}}}}