Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT02157532
Status:
SUSPENDED
Last Update Posted:
2024-09-19
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Acute Stroke Intervention Trial - the EASI Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011216', 'term': 'Practice Management, Medical'}], 'ancestors': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'whyStopped': 'Sites are not recruiting.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical (efficacy): favorable modified Rankin Score (less than or equal to 2)', 'timeFrame': '3 months', 'description': 'The efficacy of mechanical thrombectomy compared to standard stroke treatment will be evaluated using the modified Rankin scale score at 3 months. This measure includes the rate of death within 3 months'}, {'measure': 'Rate of symptomatic intracranial hemorrhage', 'timeFrame': '24 hours', 'description': 'the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded'}], 'secondaryOutcomes': [{'measure': 'Infarct evolution', 'timeFrame': '24 hours', 'description': 'the evolution of the infarct on CT will be carried out according to a semi-quantitative evaluation using the ASPECT score between the pre-treatment CT and the 24 hour cross-sectional imaging study'}, {'measure': 'Angiographic outcome in patients allocated to mechanical thrombectomy', 'timeFrame': '2 hours', 'description': 'In patients allocated to the mechanical thrombectomy arm, the occlusion state of the target vessel will be assessed at the end of the intervention according to the TICI scale'}, {'measure': 'Frequency and Severity of complications', 'timeFrame': '3 months', 'description': 'All Adverse Events'}, {'measure': 'Rate of intracranial hemorrhage', 'timeFrame': '24 hours', 'description': 'The incidence of hemorrhage on non-contrast CT at 24 hours will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Severe stroke', 'IV tPA', 'mechanical thrombectomy'], 'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '31563589', 'type': 'DERIVED', 'citation': 'Poppe AY, Jacquin G, Stapf C, Daneault N, Deschaintre Y, Gioia LC, Odier C, Labrie M, Nehme A, Nico L, Roy D, Weill A, Raymond J. A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy. J Neuroradiol. 2020 Nov;47(6):416-420. doi: 10.1016/j.neurad.2019.08.003. Epub 2019 Sep 26.'}, {'pmid': '28238522', 'type': 'DERIVED', 'citation': 'Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Poppe AY, Odier C, Lebrun LH, Guilbert F, Gentric JC, Batista A, Weill A, Roy D, Bracard S, Raymond J; EASI trial collaborators. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol. 2017 Jun;44(3):198-202. doi: 10.1016/j.neurad.2017.01.126. Epub 2017 Feb 24.'}]}, 'descriptionModule': {'briefSummary': "Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection.\n\nThe objective of the EASI trial is thus to:\n\n* To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.\n* To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (NIHSS larger than or equal to 8), evaluated at 3 months.\n\nThe design is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment.\n\n480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3 months.\n\nIV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.\n\nThe primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.\n\nThe primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.\n\nIf the primary hypothesis is validated, expected benefits of this study is a higher rate of autonomy for stroke patients with all the attendant consequences: reduction in hospital stays, and a faster return to the activities of daily life.", 'detailedDescription': "Background Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. The burden of disease may be substantial since 25% of the victims of stroke are younger than 65 years. Standard treatment is IV rtPA thrombolysis, within 3-4.5 hours of first signs. It has been shown that patients with a moderate to severe clinical score (NIHSS more than 10) have occlusion of proximal large vessels, resulting in a more adverse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Recanalization of large arteries occurs more frequently and earlier (leading to better prognosis) with arterial than with venous access. Biochemical arterial treatment appears thus of greater efficacy in terms of recanalization of large vessels, but more inconvenient with respect to setup delays. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Results of short case series and prospective multicentric non randomized studies appear favorable. The thrombus obstructing the artery is reached by endovascular means and mechanically removed with the result that orthograde blood flow is re-established in the cerebral territory involved in the ischemia. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection. Mechanical thrombolysis should thus lead to better results than injection of an arterial thrombolytic agent, as well as increase the time window for treatment. In addition, hemorrhagic complications should be reduced.\n\nObjectives\n\nIn situations where IV rtPA thrombolysis is not optimal, that is in presumed embolic occlusions of large intracranial arterial trunks (terminal carotid, initial segment of the MCA, distal third of the basilar trunk) with a moderate to severe clinical state (NIHSS greater or equal to 8) and in situations when IV rtPA may be contra-indicated:\n\n* To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.\n* To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (greater or equal to 8), evaluated at 3 months.\n\nDesign EASI is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment. All adults presenting less than 5 hours after the beginning of symptoms with an NIHSS greater or equal to 8 discordant with imaging data are eligible. Occlusion site, when available, includes intracranial carotid artery, M1 segment of middle cerebral and basilar artery.\n\n480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (greater than 2) at 3 months, with the assumption of a 25% efficacy (mRS less or equal to 2) for IV thrombolytic treatment at 3 months.\n\nRandomization may take place any time following admission, including during IV thrombolysis. The choice of early randomization, without knowledge of the clinical or angiographic results of IV thrombolysis fulfils several objectives: allow timely delivery of a proven treatment; prevent unnecessary exposure to angiography risks; set up thrombectomy as fast as possible for a maximal efficacy.\n\nIV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.\n\nFollow-up includes brain imaging and the mRS at 3 months.\n\nEndpoint measures include:\n\n* Clinical endpoints as measured by the neurologist, and include the NIHSS at baseline and the mRS at 3 months.\n* Safety data: complications, death at 3 months, hemorrhage according to 24 hours CT scan.\n\nThe primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.\n\nThe primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.\n\nSecondary efficacy endpoints include:\n\n* Comparison of ASPECTS score between baseline and 24 hours CT scans\n* In thrombectomy group, blood flow in treated territory as measured by a TICI reperfusion score of 2 or 3 at end of treatment.\n\nSecondary safety endpoints include\n\n* Rate of hemorrhage on 24 hours CT scan\n* Frequency and severity of complications of standard treatment\n* Frequency and severity of arterial complications in thrombectomy group\n* Frequency and severity of complications at puncture site in thrombectomy group"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18\n* NIHSS greater than or equal to 8\n* onset of symptoms is less than 5 hours OR symptom/imaging mismatch\n* suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.\n\nExclusion Criteria:\n\n* established infarction of the target symptomatic territory\n* co-morbid diseases which suggest a poor 90 day outcome irrespective of management\n* radiologic evidence of hemorrhagic transformation of the infarcted territory'}, 'identificationModule': {'nctId': 'NCT02157532', 'acronym': 'EASI', 'briefTitle': 'Endovascular Acute Stroke Intervention Trial - the EASI Trial', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Intra-arterial Thrombectomy as an Acute Treatment Intervention for Stoke: the Endovascular Acute Stoke Intervention (EASI) Trial', 'orgStudyIdInfo': {'id': 'CE 12.224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Best standard treatment', 'description': 'intravenous r-tPA or any other medical management', 'interventionNames': ['Drug: Best standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical thrombectomy', 'description': 'Endovascular mechanical thrombectomy with stent-retrievers', 'interventionNames': ['Procedure: mechanical thrombectomy']}], 'interventions': [{'name': 'mechanical thrombectomy', 'type': 'PROCEDURE', 'description': 'Mechanical thrombectomy using any already approved stent-retriever device', 'armGroupLabels': ['Mechanical thrombectomy']}, {'name': 'Best standard treatment', 'type': 'DRUG', 'otherNames': ['Medical management'], 'description': 'Intravenous r-tPA infusion or any other medical management option', 'armGroupLabels': ['Best standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jean Raymond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}, {'name': 'Serge Bracard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}