Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT03412851
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COmparing CeNters ThRombectomy Aspiration STentretriever
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified rankin scale (mRs) at 90 days [effectiveness]', 'timeFrame': '90 days', 'description': 'Is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.\n\nScore Description: The scale runs from 0-6, running from perfect health without symptoms to death.\n\n0 No symptoms at all\n\nNo significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead \\[Time Frame: 90 days\\]'}], 'secondaryOutcomes': [{'measure': 'Symptomatic intracranial bleeding [safety of the technique]', 'timeFrame': 'First 14 days', 'description': 'The rate of patients with intracranial hemorrhage (measured by computed tomography) with worsening of 4 points on the NIHSS scale will be evaluated.'}, {'measure': 'Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]', 'timeFrame': 'Up to 24 hours after endovascular reperfusion', 'description': 'After endovascular reperfusion technique, TICI score will be evaluated in all consecutive patients. The rate of TICI 2b-3 will be recorded as a effectiveness endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombectomy', 'Stentriever', 'ADAPT'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).\n* Subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel.\n* Subjects older than 18 yo.\n* Subjects with a prestroke modified Rankin scale of 0-2 and presenting with an NIHSS of 2-30.\n* Subjects that the operator feels may be treated with endovascular therapy\n* Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better.\n* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration). In those Patients of more than 8 hours or awake stroke or of unknown onset should be individualized the treatment and must exist area of penumbra in CT perfusion\n* Subjects who have consented in accordance with local Institutional Review Board requirements\n\nExclusion Criteria:\n\n* Absence of large vessel occlusion on neuroimaging.\n* Platelet count \\< 100 x 10³ cells/mm³ or known platelet dysfunction.\n* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging).\n* Previously documented contrast allergy that is not amenable to medical treatment.\n* Women who are pregnant or breastfeeding at time of intervention.\n* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital.'}, 'identificationModule': {'nctId': 'NCT03412851', 'acronym': 'CONTRAST', 'briefTitle': 'COmparing CeNters ThRombectomy Aspiration STentretriever', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Universitarios Virgen del Rocío'}, 'officialTitle': 'COmparing CeNters ThRombectomy Aspiration STentretriever', 'orgStudyIdInfo': {'id': 'CO-18-V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A Direct Aspiration First Pass Technique', 'interventionNames': ['Other: A Direct Aspiration First Pass Technique']}, {'label': 'Stentriever Thrombectomy', 'interventionNames': ['Other: Stentriever Thrombectomy']}], 'interventions': [{'name': 'A Direct Aspiration First Pass Technique', 'type': 'OTHER', 'description': 'Distal aspiration technique', 'armGroupLabels': ['A Direct Aspiration First Pass Technique']}, {'name': 'Stentriever Thrombectomy', 'type': 'OTHER', 'description': 'Thrombectomy with stent retriever', 'armGroupLabels': ['Stentriever Thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bilbao', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alain Luna', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Delgado, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Pablo Alcazar, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Las Palmas de Gran Canaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Yeray Aguilar, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Insular de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joaquin Zamarro, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Oviedo', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Vega, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'San Sebastián', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Navia, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'city': 'Santander', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andrés González Mandly, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Valladolid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Arenillas, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'centralContacts': [{'name': 'Alejandro González, MD, PhD', 'role': 'CONTACT', 'email': 'ggjandro@gmail.com', 'phone': '+34 696646686'}], 'overallOfficials': [{'name': 'Alejandro González, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alejandro González', 'investigatorAffiliation': 'Hospitales Universitarios Virgen del Rocío'}}}}