Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT02407457
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2015-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'strifskin@endologix.com', 'phone': '949-599-8860', 'title': 'Sharone Trifskin', 'organization': 'Endologix, Inc.'}, 'certainAgreement': {'otherDetails': "PI shall be free to publish Institution's data/results from the Clinical Study at time of multicenter results published, notification that publication is not planned, or 18 months after the study conclusion at all centers, whichever occurs first.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs are collected through 5 year follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 167, 'seriousNumAtRisk': 376, 'deathsNumAffected': 64, 'seriousNumAffected': 150}, {'id': 'EG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 162, 'seriousNumAtRisk': 358, 'deathsNumAffected': 50, 'seriousNumAffected': 136}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 68, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 62, 'numAffected': 38}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 67, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 72, 'numAffected': 63}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 63, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 68, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 51, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 58, 'numAffected': 44}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urogenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 53, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 46, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignancies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Aneurysm Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 68, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 62, 'numAffected': 38}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignancies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 53, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 46, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 40, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 376, 'numEvents': 61, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 66, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Absence of Aneurysm Related Complications (ARC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'ARC is a composite of the most relevant EVAR outcomes and includes:\n\n* Peri-Operative Death (\\< 30 days)\n* Rupture\n* Conversion to OSR\n* Endoleaks; post-operative\n* Migration (≥ 10mm)\n* Aneurysm Enlargement (≥ 5mm)\n* Endograft Limb Occlusions\n* Reinterventions for device- or aneurysm-related complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of MAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': 'Bleeding : 30 days', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding : 12 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding : 24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding : 36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding : 48 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding : 60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 30 days', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 12 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 24 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 36 Months', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 48 Months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac : 60 Months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'GI : 30 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GI : 12 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GI : 24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GI : 36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GI : 48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GI : 60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 30 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 12 Months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 24 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 36 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 48 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malignancies : 60 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 30 days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 12 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 24 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 36 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Miscellaneous : 60 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 30 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 12 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 24 Months', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 36 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 48 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neurological : 60 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 30 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 12 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 24 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 48 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : 60 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 30 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 12 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal : 60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 30 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wound : 60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 30 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 36 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 48 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular : 60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days, 12 months, and annually up to five years', 'description': 'Major Adverse Events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Aneurysm Related Complications (ARC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post 12 Months up to Five Years', 'description': 'ARC is a composite outcome', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Aneurysm Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '1 Year', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3 Years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4 Years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '5 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Death related to the aneurysm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Type Ia Endoleaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Type Ib Endoleaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Endoleaks Type II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Endoleaks Type IIIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Endoleaks Type IIIb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aneurysm Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Open Conversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aneurysm Expansion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Endograft Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months and 60 Months', 'description': 'Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device-Related Secondary Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adjunctive Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'OG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraprocedural', 'description': 'Number of patients with adjunctive procedure during the implant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'FG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '1 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'missed visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': '6-Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'missed visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Open Repair', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '1 Year', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Open Repair', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '2-year', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Open Repair', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '3-year', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}, {'title': '4-year', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}, {'title': '5-year', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Due to the time frame of the study - subjects have not passed 5-year.', 'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nAFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.'}, {'id': 'BG001', 'title': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.\n\nFDA Approved EVAR AAA Graft Systems'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '8', 'groupId': 'BG000'}, {'value': '72', 'spread': '8', 'groupId': 'BG001'}, {'value': '72', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}, {'title': 'Non-caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA Classification', 'classes': [{'title': 'ASA Class 1/2', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'ASA Class 3/4/5', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The first row (ASA Class 1 / 2) reflects patients with fewer health concerns and the second row (Class 3/4/5), reflects patients with more severe medical co-morbidities. \\*\\*Note, this data reflects counts of participants, not frequency.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-29', 'size': 566536, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-28T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2015-03-06', 'resultsFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Absence of Aneurysm Related Complications (ARC)', 'timeFrame': '1 year', 'description': 'ARC is a composite of the most relevant EVAR outcomes and includes:\n\n* Peri-Operative Death (\\< 30 days)\n* Rupture\n* Conversion to OSR\n* Endoleaks; post-operative\n* Migration (≥ 10mm)\n* Aneurysm Enlargement (≥ 5mm)\n* Endograft Limb Occlusions\n* Reinterventions for device- or aneurysm-related complications'}], 'secondaryOutcomes': [{'measure': 'The Number of MAEs', 'timeFrame': 'At 30 days, 12 months, and annually up to five years', 'description': 'Major Adverse Events'}, {'measure': 'The Number of Participants With Aneurysm Related Complications (ARC)', 'timeFrame': 'Post 12 Months up to Five Years', 'description': 'ARC is a composite outcome'}, {'measure': 'The Number of Participants With Aneurysm Related Mortality', 'timeFrame': 'Up to Five Years', 'description': 'Death related to the aneurysm'}, {'measure': 'Number of Type Ia Endoleaks', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.'}, {'measure': 'Number of Type Ib Endoleaks', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.'}, {'measure': 'Number Endoleaks Type II', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.'}, {'measure': 'Number of Endoleaks Type IIIa', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.'}, {'measure': 'Number of Endoleaks Type IIIb', 'timeFrame': 'Up to Five Years', 'description': 'Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.'}, {'measure': 'Number of Participants With Aneurysm Rupture', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months'}, {'measure': 'Number of Participants With Open Conversion', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months'}, {'measure': 'Number of Participants With Aneurysm Expansion', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months'}, {'measure': 'Number of Patients With Endograft Occlusion', 'timeFrame': '12 Months, 24 Months, 36 Months, 48 Months and 60 Months', 'description': 'Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months'}, {'measure': 'Number of Participants With Device-Related Secondary Interventions', 'timeFrame': '30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months', 'description': 'Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months'}, {'measure': 'Number of Patients With Adjunctive Procedures', 'timeFrame': 'Intraprocedural', 'description': 'Number of patients with adjunctive procedure during the implant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '15483279', 'type': 'BACKGROUND', 'citation': 'Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.'}, {'pmid': '3220297', 'type': 'BACKGROUND', 'citation': "Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian."}, {'pmid': '15351191', 'type': 'BACKGROUND', 'citation': 'Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.'}, {'pmid': '20096611', 'type': 'BACKGROUND', 'citation': 'Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.'}, {'pmid': '22640466', 'type': 'BACKGROUND', 'citation': 'Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.'}, {'pmid': '20484396', 'type': 'BACKGROUND', 'citation': 'De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.'}, {'pmid': '37068528', 'type': 'DERIVED', 'citation': 'Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.', 'detailedDescription': 'This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.\n\nRandomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.\n\nUp to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female at least 18 years old\n2. Subjects with minimum of 2 year life expectancy\n3. Subjects have signed the informed consent document for data release\n4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.\n\nExclusion Criteria:\n\n1. Currently participating in another study where primary endpoint has not been reached yet\n2. Known allergy to any of the device components\n3. Pregnant (females of childbearing potential only)\n4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR'}, 'identificationModule': {'nctId': 'NCT02407457', 'acronym': 'LEOPARD', 'briefTitle': 'Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endologix'}, 'officialTitle': 'Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD', 'orgStudyIdInfo': {'id': 'CP-0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AFX EVAR AAA Graft System', 'description': 'Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.', 'interventionNames': ['Device: AFX EVAR AAA Graft System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FDA Approved EVAR AAA Graft Systems', 'description': 'Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.', 'interventionNames': ['Device: FDA Approved EVAR AAA Graft Systems']}], 'interventions': [{'name': 'AFX EVAR AAA Graft System', 'type': 'DEVICE', 'description': 'Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.', 'armGroupLabels': ['AFX EVAR AAA Graft System']}, {'name': 'FDA Approved EVAR AAA Graft Systems', 'type': 'DEVICE', 'armGroupLabels': ['FDA Approved EVAR AAA Graft Systems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35630', 'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'facility': 'Eliza Coffee Medical Center', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Huntsville Hospital', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carondelet Heart and Vascular Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Central Arkansas Veteran's Healthcare System", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach VA Hospital', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento Vascular Sugeons', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser - Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose St. Francis Health', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '61110', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '48097', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Vascular Institute of Central Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Vascular Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF/Tampa VA', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory/Grady', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Navicent Health Medical Center', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United 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