Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-28 @ 9:49 PM
Study NCT ID:
NCT04046757
Status:
UNKNOWN
Last Update Posted:
2021-12-29
First Post:
2019-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Strategy for Transfer for Mechanical Thrombectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}, {'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Score (mRS)', 'timeFrame': '3 months', 'description': 'Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death)\n\n* Good outcome : 0 to 2\n* Disability : 3 to 5\n* Bad outcome : 5 and 6'}], 'secondaryOutcomes': [{'measure': 'Incidence of mechanical thrombectomy treatment', 'timeFrame': '24 hours', 'description': 'Safety of medical complication\n\nComplications of mechanical thrombectomy :\n\n* Vessel perforation\n* Intramural Arterial dissection\n* Symptomatic Intracerebral hemorrhage\n* embolization to a new territory'}, {'measure': 'Clinical evolution at 24 hours', 'timeFrame': '24 hours', 'description': 'NIHSS scale and NIHSS scale variation between the inclusion at 24 hours\n\nNational Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :\n\n* Minor stroke : 0 to 5\n* Moderate stroke 6 to 20\n* Severe stroke up to 21'}, {'measure': 'Clinical evolution 7 days', 'timeFrame': '7 days', 'description': 'NIHSS scale and NIHSS scale variation between the inclusion at 7 days\n\nNational Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :\n\n* Minor stroke : 0 to 5\n* Moderate stroke 6 to 20\n* Severe stroke up to 21'}, {'measure': 'Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.', 'timeFrame': '24 hours', 'description': 'Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.'}, {'measure': 'Symptomatic Intracerebral Haemorrhage', 'timeFrame': '24 hours', 'description': 'symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours'}, {'measure': 'Arterial Recanalisation with TICI score', 'timeFrame': 'post-act / 24 hours', 'description': 'Quality of revascularization after mechanical thrombectomy : immediate post-Mechanical-Trombectomy evaluation for patient having had mechanical thrombectomy and at 24 hours for all patient cohort.\n\nTICI score (Thrombolysis In Cerebral Infarction grading system) describe the quality of revascularization after mechanical thrombectomy (Grade 0 for no perfusion at 3 for Complete perfusion)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Mechanical Thrombectomy'], 'conditions': ['Stroke', 'Ischemic', 'Large Vessel Occlusion']}, 'descriptionModule': {'briefSummary': 'A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier', 'detailedDescription': 'Multiple RCT has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (BMT) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion.\n\nIn the Occitanie-Est region (ex Languedoc Roussillon), comprising 6 Stroke Unit, only the Comprehensive Stroke Unit of the CHU de Montpellier has a centre of interventional neuroradiology (NRI) that can perform mechanical thrombectomy.\n\nPatients suspected of stroke are referred to the nearest SU, then the candidates for thrombectomy, are transferred secondarily to the Stroke Center in Montpellier.\n\nCurrently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the Stroke Center regional reference.\n\nThe objective of the study is to compare clinical outcome on patients admitted first in the Comprehensive Stroke Center of Montpellier those transferred after Proximity Stroke Unit or directly admitted when high suspicion of large vessel occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute cerebral infarct in the arterial circulation with large vessel occlusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age\n2. With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)\n3. With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)\n4. No objection of the patient or their representative to being included in the cohort\n\nExclusion Criteria:\n\n1. Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible\n2. Predictable impossibility of patient follow-up'}, 'identificationModule': {'nctId': 'NCT04046757', 'acronym': 'START', 'briefTitle': 'Regional Strategy for Transfer for Mechanical Thrombectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region', 'orgStudyIdInfo': {'id': 'RECHMPL17_0378'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mechanical thrombectomy', 'type': 'OTHER', 'description': 'Neuroradiological endovascular treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline ARQUIZAN, MD', 'role': 'CONTACT', 'phone': 'c-arquizan@chu-montpellier.fr'}], 'facility': 'Gui De Chauliac Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Caroline ARQUIZAN, MD', 'role': 'CONTACT', 'email': 'c-arquizan@chu-montpellier.fr', 'phone': '4 67 33 72 33'}, {'name': 'Jessica HATTINGUAIS, CRA', 'role': 'CONTACT', 'email': 'j-hattinguais@chu-montpellier.fr', 'phone': '4 67 33 56 53', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Caroline ARQUIZAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}