Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 4:40 PM
Study NCT ID:
NCT00583050
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
Sponsor:
Organization:
Raw JSON
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D.', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Endovascular Aneurysm Repair', 'description': 'Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair', 'otherNumAtRisk': 1366, 'deathsNumAtRisk': 1366, 'otherNumAffected': 68, 'seriousNumAtRisk': 1366, 'deathsNumAffected': 775, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Aneurysm size increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1366, 'numAffected': 68}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Aneurysm Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1366, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Aneurysm Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Endovascular Aneurysm Repair', 'description': 'Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endovascular Aneurysm Repair', 'description': 'Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1366'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Endovascular Aneurysm Repair', 'description': 'Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1225', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '315', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1051', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1366', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of abdominal or thoracoabdominal aneurysm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1366', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1366', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-01', 'size': 802392, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-26T16:35', 'hasProtocol': True}, {'date': '2006-03-09', 'size': 531160, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-26T16:35', 'hasProtocol': False}, {'date': '2017-05-01', 'size': 802277, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-26T16:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-29', 'studyFirstPostDateStruct': {'date': '2007-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Aneurysm Rupture', 'timeFrame': '2 years', 'description': 'Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thoracoabdominal Aneurysm', 'Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '32173192', 'type': 'DERIVED', 'citation': 'Zhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.'}, {'pmid': '26792544', 'type': 'DERIVED', 'citation': 'Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.'}, {'pmid': '26620715', 'type': 'DERIVED', 'citation': 'Sylvan J, Brier C, Wolski K, Yanof J, Goel V, Kuramochi Y, Eagleton MJ. Impact of alterations in target vessel curvature on branch durability after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Mar;63(3):634-41. doi: 10.1016/j.jvs.2015.09.053. Epub 2015 Nov 29.'}, {'pmid': '25619574', 'type': 'DERIVED', 'citation': 'Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms. J Vasc Surg. 2015 Feb;61(2):355-64. doi: 10.1016/j.jvs.2014.09.068.'}, {'pmid': '25600335', 'type': 'DERIVED', 'citation': "O'Callaghan A, Greenberg RK, Eagleton MJ, Bena J, Mastracci TM. Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality. J Vasc Surg. 2015 Apr;61(4):908-14. doi: 10.1016/j.jvs.2014.10.085. Epub 2015 Jan 16."}, {'pmid': '25449006', 'type': 'DERIVED', 'citation': "O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23."}, {'pmid': '24993951', 'type': 'DERIVED', 'citation': "O'Callaghan A, Mastracci TM, Greenberg RK, Eagleton MJ, Bena J, Kuramochi Y. Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease. J Vasc Surg. 2014 Oct;60(4):914-20. doi: 10.1016/j.jvs.2013.12.053. Epub 2014 Jul 1."}, {'pmid': '24188715', 'type': 'DERIVED', 'citation': 'Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.'}, {'pmid': '23810300', 'type': 'DERIVED', 'citation': 'Mohapatra A, Greenberg RK, Mastracci TM, Eagleton MJ, Thornsberry B. Radiation exposure to operating room personnel and patients during endovascular procedures. J Vasc Surg. 2013 Sep;58(3):702-9. doi: 10.1016/j.jvs.2013.02.032. Epub 2013 Jun 28.'}, {'pmid': '23809203', 'type': 'DERIVED', 'citation': 'Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.'}, {'pmid': '23800455', 'type': 'DERIVED', 'citation': 'Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM, Roselli EE. Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms. J Vasc Surg. 2013 Sep;58(3):625-34. doi: 10.1016/j.jvs.2013.01.049. Epub 2013 Jun 22.'}, {'pmid': '23611709', 'type': 'DERIVED', 'citation': 'Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.'}, {'pmid': '23433817', 'type': 'DERIVED', 'citation': 'Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013 Apr;57(4):926-33; discussion 933. doi: 10.1016/j.jvs.2012.09.071. Epub 2013 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.', 'detailedDescription': 'The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Not pregnant\n3. Willing and able to comply with two-year follow-up period.\n4. Willing and able to give informed consent prior to enrollment\n5. No known allergy to stainless steel or polyester\n6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.\n7. Life expectancy greater than two years\n8. High risk candidate for open surgical repair\n\nExclusion Criteria:\n\nsee above'}, 'identificationModule': {'nctId': 'NCT00583050', 'briefTitle': 'Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts', 'orgStudyIdInfo': {'id': 'G010002'}, 'secondaryIdInfos': [{'id': 'IRB 4281', 'type': 'OTHER', 'domain': 'Cleveland Clinic IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endovascular Aneurysm Repair', 'description': 'Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts', 'interventionNames': ['Device: Endovascular Aneurysm Repair']}], 'interventions': [{'name': 'Endovascular Aneurysm Repair', 'type': 'DEVICE', 'otherNames': ['Cook Zenith'], 'description': 'Endovascular exclusion of aneurysm', 'armGroupLabels': ['Endovascular Aneurysm Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Behzad Farivar, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Behzad Farivar, M. D.', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}