Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-31 @ 7:11 AM
Study NCT ID:
NCT04402632
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}], 'ancestors': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-11-13', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-20', 'dispFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline', 'timeFrame': '90 days post-procedure'}], 'secondaryOutcomes': [{'measure': 'Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score', 'timeFrame': '90 days post-procedure'}, {'measure': 'Effectiveness: Incidence of hospital readmissions', 'timeFrame': '90 days post-procedure'}, {'measure': 'Effectiveness: Change in hematoma volume based on CT/MRI imaging', 'timeFrame': '90 days post-procedure'}, {'measure': 'Effectiveness: Change in hematoma thickness per CT/MRI imaging', 'timeFrame': '90 days post-procedure'}, {'measure': 'Effectiveness: Change in midline shift based on CT/MRI imaging', 'timeFrame': '90 days post-procedure'}, {'measure': 'Safety: Incidence of device-related serious adverse events', 'timeFrame': '30 days post-procedure'}, {'measure': 'Safety: Incidence of procedure-related serious adverse events', 'timeFrame': '30 days post-procedure'}, {'measure': 'Safety: Incidence of neurological death', 'timeFrame': '90 days and 180 days post-procedure'}, {'measure': 'Safety: Incidence of device-related adverse events', 'timeFrame': '90 days and 180 days post-procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Subdural Hematoma']}, 'referencesModule': {'references': [{'pmid': '39565988', 'type': 'DERIVED', 'citation': 'Davies JM, Knopman J, Mokin M, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Gross BA, Grandhi R, Tarpley J, Sivakumar W, Bain M, Crowley RW, Link TW, Fraser JF, Levitt MR, Chen PR, Hanel RA, Bernard JD, Jumaa M, Youssef P, Cress MC, Chaudry MI, Shakir HJ, Lesley WS, Billingsley J, Jones J, Koch MJ, Paul AR, Mack WJ, Osbun JW, Dlouhy K, Grossberg JA, Kellner CP, Sahlein DH, Santarelli J, Schirmer CM, Singer J, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH; EMBOLISE Investigators. Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1890-1900. doi: 10.1056/NEJMoa2313472.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-morbid Modified Rankin Score ≤3\n* Confirmed diagnosis of subacute or chronic subdural hematoma\n* Completed informed consent\n* Meets criteria for Surgery or Observation Cohort\n\nExclusion Criteria:\n\n* Life expectancy \\<1 year\n* Unable to complete follow-up\n* Pregnant, lactating, or has a positive pregnancy test at time of admission\n* Diagnosed with acute SDH\n* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization\n* Pre-randomized Markwalder Grading Scale score ≥ 3\n* Unmanaged, uncontrolled bleeding disorders/blood diathesis\n* Presumed septic embolus, or suspicion of microbial superinfection\n* Known active COVID-19 infection\n* CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography\n* Participation in another clinical trial\n* Contraindicated for the use of Onyx™ LES\n* Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization'}, 'identificationModule': {'nctId': 'NCT04402632', 'acronym': 'EMBOLISE', 'briefTitle': 'Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Neurovascular Clinical Affairs'}, 'officialTitle': 'A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)', 'orgStudyIdInfo': {'id': 'MDT19027ONYX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery Cohort: Control Arm', 'interventionNames': ['Procedure: Surgical Management']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery Cohort: Treatment Arm', 'interventionNames': ['Device: Onyx™ Liquid Embolic System (LES) Embolization', 'Procedure: Surgical Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Observational Cohort: Control Arm', 'interventionNames': ['Other: Observation Only']}, {'type': 'EXPERIMENTAL', 'label': 'Observational Cohort: Treatment Arm', 'interventionNames': ['Device: Onyx™ Liquid Embolic System (LES) Embolization']}], 'interventions': [{'name': 'Surgical Management', 'type': 'PROCEDURE', 'description': 'Surgical Evacuation of the Subdural Hematoma (SDH) (Control)', 'armGroupLabels': ['Surgery Cohort: Control Arm']}, {'name': 'Onyx™ Liquid Embolic System (LES) Embolization', 'type': 'DEVICE', 'description': 'Onyx™ LES Embolization of the Subdural Hematoma (SDH)', 'armGroupLabels': ['Surgery Cohort: Treatment Arm']}, {'name': 'Observation Only', 'type': 'OTHER', 'description': 'Medical Management (Control)', 'armGroupLabels': ['Observational Cohort: Control Arm']}, {'name': 'Onyx™ Liquid Embolic System (LES) Embolization', 'type': 'DEVICE', 'description': 'Onyx™ LES Embolization of the Subdural Hematoma (SDH)', 'armGroupLabels': ['Observational Cohort: Treatment Arm']}, {'name': 'Surgical Management', 'type': 'PROCEDURE', 'description': 'Surgical Evacuation of the Subdural Hematoma (SDH)', 'armGroupLabels': ['Surgery Cohort: Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1932', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB) Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85710', 'city': 'Tucson', 'state': 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'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann-Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508-0001', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Medical Center - Temple', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104-2420', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Jared Knopman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center'}, {'name': 'Jason Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buffalo General Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Neurovascular Clinical Affairs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}