Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT04236856
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CorPath® GRX Neuro Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hamid.rai@siemens-healthineers.com', 'phone': '6173012445', 'title': 'Clinical Scientist', 'organization': 'Corindus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 21, 'seriousNumAtRisk': 117, 'deathsNumAffected': 1, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Site Access Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrolyte Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensory Deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Galactorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemianopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Access Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Digestive Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extremity Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flow Diverter Endovascular Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraprocedural Aneurysm Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforated Sigmoid Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Relapsed Leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right radial pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Procedural Technical Success.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure.', 'description': 'The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Intra- and Peri-procedural Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.', 'description': 'The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Robotically Navigate Device to the Target Aneurysm', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as successful advancement of device to the target aneurysm robotically.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Robotically Deploy Therapeutic Device Into the Target Aneurysm', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as successful deployment of therapeutic device into the target aneurysm robotically', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Overall Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '117.3', 'spread': '47.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '27.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Total fluoroscopy utilized during the procedure as recorded by the Imaging System', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Radiation Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '6886135.5', 'spread': '25767850.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure', 'unitOfMeasure': 'mGy*cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Contrast Fluid Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '185.4', 'spread': '82.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Total contrast used during the procedure', 'unitOfMeasure': 'cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'timeFrame': 'Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th', 'description': 'All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Thromboembolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).', 'description': 'Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Devices Used Robotically', 'timeFrame': 'Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day', 'description': 'Recorded as successful or unsuccessful in conjunction with the CorPath GRX System', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aneurysm Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'title': 'Raymond Roy Classification Scale 1', 'measurements': [{'value': '96', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 3A', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 3B', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 180 Day Follow-up', 'description': 'Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory.\n\nRaymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aneurysm Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'classes': [{'categories': [{'title': 'Raymond Roy Classification Scale 1', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 2', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 3A', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Raymond Roy Classification Scale 3B', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed During Procedure (Post Intervention)', 'description': 'Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory.\n\nRaymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The clinical investigation started with enrollment of first subject on 21 August 2020 and subject recruitment was completed on 21 April 2022. With 10 investigational sites, up to 120 subjects were enrolled in order to achieve at least 108 subjects in the study; each site was initially approved to recruit a maximum of 20 subjects. The total study duration was 24 months: the recruitment phase was 18 months and follow-up continues to 180 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.\n\nRobotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-21', 'size': 784116, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-26T15:22', 'hasProtocol': True}, {'date': '2022-06-20', 'size': 433881, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-26T15:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2020-01-02', 'resultsFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-13', 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Procedural Technical Success.', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure.', 'description': 'The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy.'}, {'measure': 'Number of Intra- and Peri-procedural Events.', 'timeFrame': 'Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.', 'description': 'The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Robotically Navigate Device to the Target Aneurysm', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as successful advancement of device to the target aneurysm robotically.'}, {'measure': 'Robotically Deploy Therapeutic Device Into the Target Aneurysm', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as successful deployment of therapeutic device into the target aneurysm robotically'}, {'measure': 'Overall Procedure Time', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter'}, {'measure': 'Fluoroscopy Time', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Total fluoroscopy utilized during the procedure as recorded by the Imaging System'}, {'measure': 'Patient Radiation Exposure', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure'}, {'measure': 'Contrast Fluid Volume', 'timeFrame': 'Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.', 'description': 'Total contrast used during the procedure'}, {'measure': 'Adverse Events', 'timeFrame': 'Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th', 'description': 'All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;'}, {'measure': 'Number of Thromboembolic Events', 'timeFrame': 'Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).', 'description': 'Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure'}, {'measure': 'Devices Used Robotically', 'timeFrame': 'Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day', 'description': 'Recorded as successful or unsuccessful in conjunction with the CorPath GRX System'}, {'measure': 'Number of Participants With Aneurysm Occlusion', 'timeFrame': 'Assessed at 180 Day Follow-up', 'description': 'Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory.\n\nRaymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.'}, {'measure': 'Number of Participants With Aneurysm Occlusion', 'timeFrame': 'Assessed During Procedure (Post Intervention)', 'description': 'Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory.\n\nRaymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Aneurysm', 'Subarachnoid Hemorrhage', 'Headache']}, 'referencesModule': {'references': [{'pmid': '28723321', 'type': 'BACKGROUND', 'citation': 'Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.'}, {'pmid': '26330064', 'type': 'BACKGROUND', 'citation': 'Lantigua H, Ortega-Gutierrez S, Schmidt JM, Lee K, Badjatia N, Agarwal S, Claassen J, Connolly ES, Mayer SA. Subarachnoid hemorrhage: who dies, and why? Crit Care. 2015 Aug 31;19(1):309. doi: 10.1186/s13054-015-1036-0.'}, {'pmid': '22556195', 'type': 'BACKGROUND', 'citation': 'Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.'}, {'pmid': '23406828', 'type': 'BACKGROUND', 'citation': 'Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.'}, {'pmid': '18523626', 'type': 'BACKGROUND', 'citation': 'Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.'}, {'pmid': '37793795', 'type': 'DERIVED', 'citation': 'Mendes Pereira V, Rice H, De Villiers L, Sourour N, Clarencon F, Spears J, Tomasello A, Hernandez D, Cancelliere NM, Liu XYE, Nicholson P, Costalat V, Gascou G, Mordasini P, Gralla J, Martinez-Galdamez M, Galvan Fernandez J, Killer-Oberpfalzer M, Liebeskind DS, Turner RD, Blanc R, Piotin M. Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. J Neurointerv Surg. 2024 Mar 14;16(4):405-411. doi: 10.1136/jnis-2023-020161.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.', 'detailedDescription': 'This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \\>1.5 or aneurysm neck width \\>4.0 mm.\n3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.\n4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.\n2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.\n3. Women who are pregnant.\n4. Persons under guardianship or curatorship.'}, 'identificationModule': {'nctId': 'NCT04236856', 'briefTitle': 'CorPath® GRX Neuro Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corindus Inc.'}, 'officialTitle': 'An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms', 'orgStudyIdInfo': {'id': '104-08660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Robotic Endovascular Procedure', 'description': 'Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.', 'interventionNames': ['Device: Robotic Endovascular Procedure']}], 'interventions': [{'name': 'Robotic Endovascular Procedure', 'type': 'DEVICE', 'otherNames': ['CorPath GRX System'], 'description': 'After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.', 'armGroupLabels': ['Robotic Endovascular Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast University Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'city': 'Salzburg', 'country': 'Austria', 'facility': 'Uniklinikum Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '75013', 'city': 'Paris', 'state': 'CA', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier - Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75940', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Fondation Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'University Clinical Hospital of Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Michel Piotin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interventional Neuroradiologisit & Director, Foundation Rothschild'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corindus Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}