Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT07250958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-rupture incidence', 'timeFrame': 'From procedure to 90-days post procedure.', 'description': 'Detected on head CT'}], 'secondaryOutcomes': [{'measure': 'Functional Outcome', 'timeFrame': '90 days (+-14 days) post procedure', 'description': 'Measured on Modified Rankin Scale (MRS) Scored 0-6 where 0-No disability, 1=no significant disability, 2= slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability, 6=dead. The higher the score the worse the outcome.'}, {'measure': 'Accomplishment of Dome protection', 'timeFrame': 'From procedure through 90-days post procedure', 'description': 'Based on angiographic goals: 1) partial coil obliteration of the aneurysm dome or increased contrast stasis within the aneurysm dome compared to pre-embolization angiography, 2) filling of the aneurysm neck, 3) no filling of the aneurysm dome wall, and 4) no filling of the aneurysm rupture site or extra-aneurysmal contrast extravasation.'}, {'measure': 'Procedural complications during the dome-protection and delayed final procedures on the aneurysm', 'timeFrame': 'Time of procedure through 90 days post procedure', 'description': 'Collection of adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.', 'detailedDescription': 'To prospectively capture data of patients treated with the guideline-recommended, standard-of-care dome-protection approach. The data will be used to determine:\n\n* (Primary) Incidence of aneurysm re-rupture by 90 days, censored at the time of definitive aneurysm treatment or death, detected on a surveillance head CT or one obtained after a neurological decline.\n* (Secondary) Measure functional status of patients around 90 days (+/- 14 days)\n* (Secondary) Measure success of dome protection as determined by angiographic criteria and procedural complications\n\nDOME protection is a treatment approach for patients who suffered a severe brain bleed due to an aneurysm. Instead of performing immediate, extensive surgery, this study investigates a minimally invasive procedure called "dome protection", which involves placing tiny coils to patch the most fragile part of the aneurysm. This method aims to prevent re-bleeding and allow the patient to stabilize before undergoing full aneurysm repair. The findings could lead to improved health outcomes in patients with aneurysmal subarachnoid hemorrhage by reducing procedure-related risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* CT confirmed aSAH with an angiographically detected aneurysm\n* World Federation of Neurological Sciences (WFNS) aSAH grade 3-5 aneurysm\n* LAR available and gives consent within 72 hours after the onset of aSAH (or last known normal\n\nExclusion Criteria:\n\n* Patients whose aneurysm judged appropriate for balloon-assisted coiling\n* Patients whose aneurysm is bleeding from the "neck"\n* Patients who are clinically judged to suffer imminent death within 24 hours.\n* Pregnancy or positive urine pregnancy test'}, 'identificationModule': {'nctId': 'NCT07250958', 'acronym': 'DOME', 'briefTitle': 'Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study', 'orgStudyIdInfo': {'id': '25.0321'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Term', 'investigatorFullName': 'Akshitkumar MIstry', 'investigatorAffiliation': 'University of Louisville'}}}}