Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-01-24 @ 8:13 PM
Study NCT ID:
NCT02444832
Status:
UNKNOWN
Last Update Posted:
2015-05-15
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D017542', 'term': 'Aneurysm, Ruptured'}], '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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-14', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Aneurysm Coiling (no residual cerebral aneurysm)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '1 year'}, {'measure': 'Neurological Outcome (classified with the Glasgow Outcome Scale, Rankin Scale)', 'timeFrame': '1 year', 'description': 'All patients will be classified with the Glasgow Outcome Scale, Rankin Scale.'}, {'measure': 'Procedural device-related serious adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intracranial Aneurysm', 'Anterior Communicating Artery Aneurysm', 'Cerebral Aneurysm', 'Aneurysm, Ruptured']}, 'referencesModule': {'references': [{'pmid': '14565533', 'type': 'BACKGROUND', 'citation': 'Elias T, Ogungbo B, Connolly D, Gregson B, Mendelow AD, Gholkar A. Endovascular treatment of anterior communicating artery aneurysms: results of clinical and radiological outcome in Newcastle. Br J Neurosurg. 2003 Jun;17(3):278-86. doi: 10.1080/0268869031000153251.'}, {'pmid': '8957810', 'type': 'BACKGROUND', 'citation': 'Moret J, Pierot L, Boulin A, Castaings L, Rey A. Endovascular treatment of anterior communicating artery aneurysms using Guglielmi detachable coils. Neuroradiology. 1996 Nov;38(8):800-5. doi: 10.1007/s002340050352.'}, {'pmid': '16823299', 'type': 'BACKGROUND', 'citation': 'Birknes JK, Hwang SK, Pandey AS, Cockroft K, Dyer AM, Benitez RP, Veznedaroglu E, Rosenwasser RH. Feasibility and limitations of endovascular coil embolization of anterior communicating artery aneurysms: morphological considerations. Neurosurgery. 2006 Jul;59(1):43-52; discussion 43-52. doi: 10.1227/01.NEU.0000219220.25721.B9.'}, {'pmid': '16139655', 'type': 'BACKGROUND', 'citation': 'Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5.'}]}, 'descriptionModule': {'briefSummary': 'Based on the anatomical features of the anterior Communicating artery complex, the investigators will analyze the outcome of the ACoA aneurysms treated by endovascular therapy.\n\nThe most common site of intracranial aneurysms is the anterior communicating artery (AcomA). AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.\n\nRecent publications have addressed specifically the endovascular treatment of AcoA aneurysms. Furthermore, detailed anatomic characteristics and the effects of the multiple variations of the anterior communicating artery complex have scarcely been reported.\n\nThe hemodynamic factors play a fundamental role in the adequate treatment of aneurismal coiling.\n\nThe objective of our registry is to analyze the impact of morphological configuration of the anterior communicating artery complex and the results of coil embolization in AcoA aneurysms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Communicating Artery Aneurysm treated with endovascular coiling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Anterior Communicating Artery Aneurysm treated with endovascular coiling.\n\nExclusion Criteria:\n\n* Patients without imaging follow up of at least 12 months after endovascular treatment.'}, 'identificationModule': {'nctId': 'NCT02444832', 'acronym': 'MACAARET', 'briefTitle': 'Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy', 'orgStudyIdInfo': {'id': 'NeurovascCDI001'}}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Zarco, MD', 'role': 'CONTACT', 'email': 'fzarco@clinic.ub.es', 'phone': '932 27 54 00', 'phoneExt': '2662'}, {'name': 'Federico', 'role': 'CONTACT'}, {'name': 'Federico Zarco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonio Lopez Rueda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juan Macho Fernandez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fernando Delgado, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alejandro González García, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mariano Werner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oscar Chirife, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Napoleón Macias, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luis San Roman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jordi Blasco, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Federico Zarco, MD', 'role': 'CONTACT', 'email': 'fzarco@clinic.ub.es', 'phone': '932275400', 'phoneExt': '2662'}], 'overallOfficials': [{'name': 'Federico Zarco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Universitario Reina Sofia de Cordoba', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurorradiologist,', 'investigatorFullName': 'Federico Zarco', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}