Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:37 PM
Study NCT ID:
NCT07324551
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Navigation/procedure time', 'timeFrame': '2 years', 'description': 'Comparing between devices on both navigation and procedure time'}, {'measure': 'Final Embolization Grades', 'timeFrame': '2 Years', 'description': 'Comparison between device groups for final embolization grades'}, {'measure': 'Incidence of AE at time of surgery', 'timeFrame': '2 Years', 'description': 'Incidence of device related adverse events and incidence of procedure related adverse events'}, {'measure': 'Incidence of recurrence of hemorrhage', 'timeFrame': '2 Years', 'description': 'Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MMA Embolization', 'cSDH', 'Chronic Subdural Hematoma'], 'conditions': ['Chronic Subdural Hematoma', 'Hemorrhage Brain']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference", 'detailedDescription': 'If you agree to take part, you will have a 50/50 chance of being assigned to one of two groups. In group 1, your procedure will use the study devices. In group 2, your procedure will use devices chosen by your surgeon. The procedure and follow up are part of standard medical care. This means that taking part in the study will not mean more time or energy compared to the usual treatment you would have.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to The Ohio State University Wexner Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patient or legally authorized representative (LAR) signs an informed consent form\n* Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood\n* Pre-morbid Modified Rankin Score of ≤ 3\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization\n* Unmanaged, uncontrolled bleeding disorders/blood diathesis\n* Presumed septic embolus, or suspicion of microbial superinfection\n* Contraindication to angiography\n* CT or MRI evidence of intra-cranial tumor or mass lesion'}, 'identificationModule': {'nctId': 'NCT07324551', 'acronym': 'SCIENTIA', 'briefTitle': 'Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center', 'orgStudyIdInfo': {'id': '20250580'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Matched pair Aristotle 14 guidewire and Plato 17 microcatheter', 'type': 'DEVICE', 'description': 'Participants will be randomized in 1:1 ratio to either use of study devices (matched pair Aristotle and Plato) or standard of care (surgeon combination preference) using block randomization method with a fixed block size of 4 ensuring 50% will be randomized to study devices group and 50% randomized to standard of care group.'}, {'name': 'Surgeon combination preference', 'type': 'DEVICE', 'description': 'Surgeon will decide the on guidewire and microcatheter to use for MMA embolization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edouard J Belizaire, BA', 'role': 'CONTACT', 'email': 'edouard.belizaire@osumc.edu', 'phone': '614-366-6936'}, {'role': 'CONTACT', 'phone': '6143666936'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Edouard Belizaire', 'role': 'CONTACT', 'email': 'edouard.belizaire@osumc.edu', 'phone': '614.366.6936'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scientia Vascular, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Patrick Youssef', 'investigatorAffiliation': 'Ohio State University'}}}}