Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01945827
Status:
WITHDRAWN
Last Update Posted:
2014-07-03
First Post:
2013-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-02', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Objective - Angiographic Outcomes', 'timeFrame': '12 Months', 'description': 'The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale'}, {'measure': 'Primary Safety Endpoint - Neurological Morbidity and Mortality', 'timeFrame': '12 months', 'description': 'Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study'}], 'secondaryOutcomes': [{'measure': 'Packing Density', 'timeFrame': '24 hours', 'description': 'Packing density as measured by volumetric filling of the aneurysm post-procedure after the coils have been placed as indicated by angiographic films taken at the end of the coiling procedure'}, {'measure': 'Recurrence Rate', 'timeFrame': '12 months'}, {'measure': 'Re-treatment Rate', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': 'The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure\n* Investigator intends to use DeltaMaxx Microcoil system during coiling procedure\n* Investigator intends to use only Codman Neuro microcoils during coiling procedure\n* Aneurysm size \\[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen\\] ≥6 mm\n* If ruptured aneurysm: Hunt and Hess 1, 2, or 3\n* If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2\n* The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.\n\nExclusion Criteria:\n\n* Prior treatment (surgical or endovascular) of the target aneurysm\n* Subjects with more than one aneurysm (\\>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.\n* Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation\n* Women who are pregnant or plan to become pregnant during the study\n* Life expectancy less than 12 months.\n* Presence of arteriovenous malformation\n* Fusiform, mycotic, traumatic, or tumoral aneurysms\n* Planned aneurysm treatment by parent vessel occlusion\n* Subject enrolled in any concurrent study'}, 'identificationModule': {'nctId': 'NCT01945827', 'briefTitle': 'Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codman & Shurtleff'}, 'orgStudyIdInfo': {'id': 'CD-000036-PRO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DeltaMaxx treated Patients', 'interventionNames': ['Device: DeltaMaxx Microcoil System']}], 'interventions': [{'name': 'DeltaMaxx Microcoil System', 'type': 'DEVICE', 'armGroupLabels': ['DeltaMaxx treated Patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codman & Shurtleff', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}