Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04526756
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2020-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, non-randomized, controlled, outcome-blinded study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2020-08-22', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptomatic intracranial haemorrhage transformation', 'timeFrame': '36 hours', 'description': 'Symptomatic intracranial haemorrhage (sICH) transformation was defined according to European Cooperative Acute Stroke Study (ECASS)-III criteria'}], 'primaryOutcomes': [{'measure': 'modified Rankin Scale(mRS) score of 0 to 2', 'timeFrame': '90 days', 'description': 'independent outcome at 90 days'}], 'secondaryOutcomes': [{'measure': 'modified Rankin Scale(mRS) score of 0 to 1', 'timeFrame': '90 days', 'description': 'excellent outcome at 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'acute large vessel occlusion', 'thrombectomy', 'mild stroke;', 'prognosis'], 'conditions': ['Ischemic Stroke', 'Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '30355094', 'type': 'RESULT', 'citation': 'Sarraj A, Hassan A, Savitz SI, Grotta JC, Cai C, Parsha KN, Farrell CM, Imam B, Sitton CW, Reddy ST, Kamal H, Goyal N, Elijovich L, Reishus K, Krishnan R, Sangha N, Wu A, Costa R, Malik R, Mir O, Hasan R, Snodgrass LM, Requena M, Graybeal D, Abraham M, Chen M, McCullough LD, Ribo M. Endovascular Thrombectomy for Mild Strokes: How Low Should We Go? Stroke. 2018 Oct;49(10):2398-2405. doi: 10.1161/STROKEAHA.118.022114.'}, {'pmid': '28384632', 'type': 'RESULT', 'citation': 'Dargazanli C, Consoli A, Gory B, Blanc R, Labreuche J, Preda C, Bourdain F, Decroix JP, Redjem H, Ciccio G, Mazighi M, Smajda S, Desilles JP, Riva R, Labeyrie PE, Coskun O, Rodesch G, Turjman F, Piotin M, Lapergue B; ETIS investigators. Is Reperfusion Useful in Ischaemic Stroke Patients Presenting with a Low National Institutes of Health Stroke Scale and a Proximal Large Vessel Occlusion of the Anterior Circulation? Cerebrovasc Dis. 2017;43(5-6):305-312. doi: 10.1159/000468995. Epub 2017 Apr 7.'}, {'pmid': '29724764', 'type': 'RESULT', 'citation': 'Shang X, Lin M, Zhang S, Li S, Guo Y, Wang W, Zhang M, Wan Y, Zhou Z, Zi W, Liu X. Clinical Outcomes of Endovascular Treatment within 24 Hours in Patients with Mild Ischemic Stroke and Perfusion Imaging Selection. AJNR Am J Neuroradiol. 2018 Jun;39(6):1083-1087. doi: 10.3174/ajnr.A5644. Epub 2018 May 3.'}, {'pmid': '29089458', 'type': 'RESULT', 'citation': 'Dargazanli C, Arquizan C, Gory B, Consoli A, Labreuche J, Redjem H, Eker O, Decroix JP, Corlobe A, Mourand I, Gaillard N, Ayrignac X, Charif M, Duhamel A, Labeyrie PE, Riquelme C, Ciccio G, Smajda S, Desilles JP, Gascou G, Lefevre PH, Mantilla-Garcia D, Cagnazzo F, Coskun O, Mazighi M, Riva R, Bourdain F, Labauge P, Rodesch G, Obadia M, Bonafe A, Turjman F, Costalat V, Piotin M, Blanc R, Lapergue B; ETIS REGISTRY Investigators. Mechanical Thrombectomy for Minor and Mild Stroke Patients Harboring Large Vessel Occlusion in the Anterior Circulation: A Multicenter Cohort Study. Stroke. 2017 Dec;48(12):3274-3281. doi: 10.1161/STROKEAHA.117.018113. Epub 2017 Oct 31.'}, {'pmid': '28768820', 'type': 'RESULT', 'citation': 'Haussen DC, Lima FO, Bouslama M, Grossberg JA, Silva GS, Lev MH, Furie K, Koroshetz W, Frankel MR, Nogueira RG. Thrombectomy versus medical management for large vessel occlusion strokes with minimal symptoms: an analysis from STOPStroke and GESTOR cohorts. J Neurointerv Surg. 2018 Apr;10(4):325-329. doi: 10.1136/neurintsurg-2017-013243. Epub 2017 Aug 2.'}, {'pmid': '30617997', 'type': 'RESULT', 'citation': 'Kaesmacher J, Chaloulos-Iakovidis P, Panos L, Mordasini P, Heldner MR, Kurmann CC, Michel P, Hajdu SD, Ribo M, Requena M, Maegerlein C, Friedrich B, Costalat V, Benali A, Pierot L, Gawlitza M, Schaafsma J, Pereira VM, Gralla J, Fischer U. Clinical effect of successful reperfusion in patients presenting with NIHSS < 8: data from the BEYOND-SWIFT registry. J Neurol. 2019 Mar;266(3):598-608. doi: 10.1007/s00415-018-09172-1. Epub 2019 Jan 8.'}, {'pmid': '34777207', 'type': 'DERIVED', 'citation': 'Liu F, Shen H, Chen C, Bao H, Zuo L, Xu X, Yang Y, Cochrane A, Xiao Y, Li G. Mechanical Thrombectomy for Acute Stroke Due to Large-Vessel Occlusion Presenting With Mild Symptoms. Front Neurol. 2021 Oct 28;12:739267. doi: 10.3389/fneur.2021.739267. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Mechanical thrombectomy(MT) has been recommended in patients with acute large vessel occlusion stroke(LVO) , especially for those with National Institutes of Health Stroke Scale (NIHSS) score ≥6. However, it is still unclear if patients with minor strokes and LVO also benefit from MT.The aim of this study was to evaluate the safety and efficacy of MT for acute LVO and mild symptoms.', 'detailedDescription': 'This is a prospective cohort study of patients with with mild ischemic stroke (NIHSS Score \\<6) and LVO. Patients were divided into 2 groups: MT or medical management.Baseline data and clinical outcomes were compared. A independent clinical outcome was defined as a modified Rankin Scale score of 0 to 2 at 90 days. A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs;\n2. age≥18 years old;\n3. the NIHSS score before evaluation of thrombectomy\\<6;\n4. large artery occlusion including Middle cerebral artery M1, proximal M2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio\\>1.8 or basilar artery and posterior cerebral artery P1 occlusion\n\nExclusion Criteria:\n\n1. Patients without prior functional independence (mRS score of \\>2)\n2. Patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography\n3. patients in control group with neurological worsening and received rescue thrombectomy'}, 'identificationModule': {'nctId': 'NCT04526756', 'briefTitle': 'Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms After Imaging Selection', 'orgStudyIdInfo': {'id': '2016-DFNE-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'patients in this group will receive mechanical thrombectomy and standardized drug treatment of acute ischemic stroke', 'interventionNames': ['Procedure: Mechanical Thrombectomy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'patients in this group will receive standardized drug treatment of acute ischemic stroke'}], 'interventions': [{'name': 'Mechanical Thrombectomy', 'type': 'PROCEDURE', 'description': 'Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200123', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Gang Li', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Gang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}