Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT03898960
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Study to Evaluate the NIMBUS Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director Clinical Research', 'organization': 'CERENOVUS'}, 'certainAgreement': {'otherDetails': 'Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 90', 'description': 'Safety set included all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).', 'eventGroups': [{'id': 'EG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 6, 'seriousNumAtRisk': 54, 'deathsNumAffected': 10, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hemianopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vascular access site pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Subarachnoid hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis hemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Successful Revascularization With NIMBUS Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '80.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \\[90-99%\\] of downstream territory; 3=Complete and 100% reperfusion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The modified intent-to-treat (mITT) analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Successful Procedural Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '89.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Successful procedural revascularization was defined as achieving an mTICI score of 2b or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in \\[90-99%\\] of downstream territory; 3=Complete and 100% reperfusion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Excellent Procedural Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '52.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Excellent procedural revascularization was defined as achieving an mTICI score of 2c or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With First Pass Revascularization Using NIMBUS Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '67.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'First Pass revascularization was defined as achieving an mTICI score of 2b or greater after the first use of NIMBUS device as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Embolization to a New Territory (ENT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with ENT was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '12.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with sICH according to the HBC was reported. sICH was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item: greater than or equal to (\\>=) 4 points total National Institute of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; \\>=2 point in one NIHSS category. The rationale for this was to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention; absence of alternative explanation for deterioration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 90', 'description': 'Number of participants with all-cause mortality at 90 days post-procedure on Day 0 was reported. All-cause mortality included all deaths of participants due to any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '73.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 90', 'description': 'Percentage of participants with mRS score of \\<=2 was reported. The mRS was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mRS analysis set consisted of all mITT participants who met study criteria as MRI criterion: volume of diffusion restriction visually assessed \\<=50 milliliter(mL), computed tomography(CT) criterion: ASPECTS 6 to 10 on baseline CT, computed tomography angiography(CTA)-source images or volume of significantly lowered cerebral blood volume(CBV) \\<=50 mL; NIHSS \\>=8 and less than (\\<)30; participants treated within 6 hours of onset of stroke symptoms (start of treatment defined as groin puncture).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mechanical Thrombectomy: NIMBUS Device', 'description': 'Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '14.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-23', 'size': 1771706, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-15T12:10', 'hasProtocol': True}, {'date': '2022-01-25', 'size': 898593, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-15T12:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Thrombus/Clot'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2019-03-29', 'resultsFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-15', 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Successful Revascularization With NIMBUS Device', 'timeFrame': 'Day 1', 'description': 'Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \\[90-99%\\] of downstream territory; 3=Complete and 100% reperfusion.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Successful Procedural Revascularization', 'timeFrame': 'Day 1', 'description': 'Successful procedural revascularization was defined as achieving an mTICI score of 2b or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in \\[90-99%\\] of downstream territory; 3=Complete and 100% reperfusion.'}, {'measure': 'Percentage of Participants With Excellent Procedural Revascularization', 'timeFrame': 'Day 1', 'description': 'Excellent procedural revascularization was defined as achieving an mTICI score of 2c or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion.'}, {'measure': 'Percentage of Participants With First Pass Revascularization Using NIMBUS Device', 'timeFrame': 'Day 1', 'description': 'First Pass revascularization was defined as achieving an mTICI score of 2b or greater after the first use of NIMBUS device as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \\[50-66%\\] of downstream territory) and 2b67 (reperfusion in \\[67-89%\\] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion.'}, {'measure': 'Percentage of Participants With Embolization to a New Territory (ENT)', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with ENT was reported.'}, {'measure': 'Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with sICH according to the HBC was reported. sICH was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item: greater than or equal to (\\>=) 4 points total National Institute of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; \\>=2 point in one NIHSS category. The rationale for this was to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention; absence of alternative explanation for deterioration.'}, {'measure': 'Number of Participants With All-Cause Mortality', 'timeFrame': 'Up to Day 90', 'description': 'Number of participants with all-cause mortality at 90 days post-procedure on Day 0 was reported. All-cause mortality included all deaths of participants due to any cause.'}, {'measure': 'Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2', 'timeFrame': 'Up to Day 90', 'description': 'Percentage of participants with mRS score of \\<=2 was reported. The mRS was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Stroke']}, 'descriptionModule': {'briefSummary': 'A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.', 'detailedDescription': 'The objective of this study is to assess the efficacy of the NIMBUS Device. The study will also report on clot characteristics and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18\n* The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form.\n* Patient has had one or two passes of another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel.\n* mRS 0-1 prior to this stroke.\n* NIMBUS is used on the second or third overall pass to attempt revascularization.\n\nExclusion Criteria:\n\n* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.\n* Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).\n* All patients with severe hypertension on presentation (SBP \\> 220 mmHg and/or DBP \\> 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP \\>185 mmHg and/ or DBP \\>110 mmHg).\n* Known cerebral vasculitis.\n* Known cancer with life expectancy less than 12 months.\n* Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.\n* Intracranial stenosis that prevents access to the site of occlusion.\n* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.\n* Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).\n* Evidence of dissection in the extra or intracranial cerebral arteries.\n* Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)."}, 'identificationModule': {'nctId': 'NCT03898960', 'acronym': 'SPERO', 'briefTitle': 'Post Marketing Study to Evaluate the NIMBUS Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuravi Limited'}, 'officialTitle': 'Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions', 'orgStudyIdInfo': {'id': 'CNV_2018_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical Thrombectomy', 'description': 'NIMBUS Device', 'interventionNames': ['Device: NIMBUS Device']}], 'interventions': [{'name': 'NIMBUS Device', 'type': 'DEVICE', 'description': 'NIMBUS Geometric Clot Extractor', 'armGroupLabels': ['Mechanical Thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'René van den Berg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuravi Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}