Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04507334
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Secondary Rupture of Aortic Aneurysm Post EVAR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'describe survival in patient with secondary rupture aneurysm despite endovascular treatment', 'timeFrame': '20 years', 'description': 'mortality describe in the group'}], 'secondaryOutcomes': [{'measure': 'Compare survival in patients with rupture secondary aneurysm despite treatment', 'timeFrame': '20 years', 'description': 'with endovascular according to:\n\n* management of secondary rupture of the aneurysm\n* the hemodynamic state on arrival in the center treating\n* the size of the aneurysm sac'}, {'measure': '2) Explore the risk factors for mortality in study patients', 'timeFrame': '20 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '19008129', 'type': 'BACKGROUND', 'citation': 'Schlosser FJ, Gusberg RJ, Dardik A, Lin PH, Verhagen HJ, Moll FL, Muhs BE. Aneurysm rupture after EVAR: can the ultimate failure be predicted? Eur J Vasc Endovasc Surg. 2009 Jan;37(1):15-22. doi: 10.1016/j.ejvs.2008.10.011. Epub 2008 Nov 12.'}, {'pmid': '28160528', 'type': 'BACKGROUND', 'citation': 'Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430.'}, {'pmid': '21037436', 'type': 'BACKGROUND', 'citation': 'Wyss TR, Brown LC, Powell JT, Greenhalgh RM. Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials. Ann Surg. 2010 Nov;252(5):805-12. doi: 10.1097/SLA.0b013e3181fcb44a.'}, {'pmid': '9685145', 'type': 'BACKGROUND', 'citation': 'Torsello GB, Klenk E, Kasprzak B, Umscheid T. Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft. J Vasc Surg. 1998 Jul;28(1):184-7. doi: 10.1016/s0741-5214(98)70214-9.'}, {'pmid': '9685144', 'type': 'BACKGROUND', 'citation': 'Alimi YS, Chakfe N, Rivoal E, Slimane KK, Valerio N, Riepe G, Kretz JG, Juhan C. Rupture of an abdominal aortic aneurysm after endovascular graft placement and aneurysm size reduction. J Vasc Surg. 1998 Jul;28(1):178-83. doi: 10.1016/s0741-5214(98)70213-7.'}, {'pmid': '14532875', 'type': 'BACKGROUND', 'citation': 'Fransen GA, Vallabhaneni SR Sr, van Marrewijk CJ, Laheij RJ, Harris PL, Buth J; EUROSTAR. Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry. Eur J Vasc Endovasc Surg. 2003 Nov;26(5):487-93. doi: 10.1016/s1078-5884(03)00350-2.'}, {'pmid': '12042725', 'type': 'BACKGROUND', 'citation': 'Bernhard VM, Mitchell RS, Matsumura JS, Brewster DC, Decker M, Lamparello P, Raithel D, Collin J. Ruptured abdominal aortic aneurysm after endovascular repair. J Vasc Surg. 2002 Jun;35(6):1155-62. doi: 10.1067/mva.2002.123758.'}]}, 'descriptionModule': {'briefSummary': 'Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications: only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as a few cases reports This study, the first carried out in France, aims to describe the survival in patients with secondary rupture of the aneurysm despite initial treatment with EVAR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with ruptured aortic aneurysm + EVAR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patient who had a ruptured aortic aneurysm between 01/01/1993 and 07/31/2020)\n* Patients whose aortic aneurysm has been treated with EVAR\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT04507334', 'briefTitle': 'Secondary Rupture of Aortic Aneurysm Post EVAR', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Secondary Rupture of Aortic Aneurysm After EVAR Management', 'orgStudyIdInfo': {'id': 'ID-RCB/EUDRACT'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'camille salomon', 'role': 'CONTACT', 'email': 'salomoncamille@gmail.com', 'phone': '0688027932'}, {'name': 'Serguei Malikov', 'role': 'CONTACT', 'email': 's.malikov@chru-nancy.fr', 'phone': '0679322495'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}