Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT01070069
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2010-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
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': 'ehebb@endologix.com', 'phone': '949-598-4628', 'title': 'Elisa Hebb', 'organization': 'Endologix'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'description': 'All Adverse Events were monitored/assessed without regard to the specific adverse event term.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR', 'otherNumAtRisk': 50, 'otherNumAffected': 42, 'seriousNumAtRisk': 50, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device', 'otherNumAtRisk': 50, 'otherNumAffected': 44, 'seriousNumAtRisk': 50, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device', 'otherNumAtRisk': 51, 'otherNumAffected': 39, 'seriousNumAtRisk': 51, 'seriousNumAffected': 19}, {'id': 'EG003', 'title': 'PEVAR (Prostar XL Roll -In)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.', 'otherNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'PEVAR (ProGlide Roll -In)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.', 'otherNumAtRisk': 22, 'otherNumAffected': 20, 'seriousNumAtRisk': 22, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Blood and Lymph Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Eye Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'GI Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'General Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'injury and Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 54, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 43, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 23, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Metabolism/Nutritional Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Psychiatric Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Renal and Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Reproductive Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Respiratory/Thoracic Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Skin Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Surgical/Medical Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}], 'seriousEvents': [{'term': 'Blood and Lymph Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Cardiac Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'GI Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'General Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Injury and Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Metabolism/Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Renal and Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Respiratory/Thoracic Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Surgical/Medical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}], 'classes': [{'categories': [{'title': 'Subjects with Treatment Success', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}, {'title': 'Subjects with unsuccessful Treatment', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator:\n\n* Procedural technical success\n* Absence of vascular complication\n* Absence of major adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PEVAR (Prostar XL Roll-in) and PEVAR (ProGlide Roll-in) were not part of the primary endpoint analysis cohort and hence not included in this section.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (ProStar XL Roll-in)', 'description': 'PEVAR performed with the ProStar XL suture mediated closure system.'}], 'classes': [{'title': 'Patients with at least 1 SAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'General disorders and administration site conditions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Surgical and medical procedures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAEs Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).'}, {'type': 'SECONDARY', 'title': 'SF-36 (Health-related Quality of Life Survey)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll-in)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'Physical Function at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '27', 'groupId': 'OG000'}, {'value': '71', 'spread': '27', 'groupId': 'OG001'}, {'value': '60', 'spread': '26', 'groupId': 'OG002'}, {'value': '58', 'spread': '26', 'groupId': 'OG003'}, {'value': '70', 'spread': '21', 'groupId': 'OG004'}]}]}, {'title': 'Role Limitations due to Physical Health at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '47', 'spread': '46', 'groupId': 'OG000'}, {'value': '59', 'spread': '40', 'groupId': 'OG001'}, {'value': '51', 'spread': '45', 'groupId': 'OG002'}, {'value': '51', 'spread': '44', 'groupId': 'OG003'}, {'value': '43', 'spread': '41', 'groupId': 'OG004'}]}]}, {'title': 'Role Limitations due to Emotional Health at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '42', 'groupId': 'OG000'}, {'value': '68', 'spread': '40', 'groupId': 'OG001'}, {'value': '78', 'spread': '38', 'groupId': 'OG002'}, {'value': '67', 'spread': '44', 'groupId': 'OG003'}, {'value': '79', 'spread': '34', 'groupId': 'OG004'}]}]}, {'title': 'Energy/Fatigue at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '24', 'groupId': 'OG000'}, {'value': '55', 'spread': '25', 'groupId': 'OG001'}, {'value': '51', 'spread': '21', 'groupId': 'OG002'}, {'value': '52', 'spread': '25', 'groupId': 'OG003'}, {'value': '63', 'spread': '20', 'groupId': 'OG004'}]}]}, {'title': 'Mental Health at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '79', 'spread': '19', 'groupId': 'OG000'}, {'value': '73', 'spread': '20', 'groupId': 'OG001'}, {'value': '82', 'spread': '15', 'groupId': 'OG002'}, {'value': '82', 'spread': '17', 'groupId': 'OG003'}, {'value': '87', 'spread': '19', 'groupId': 'OG004'}]}]}, {'title': 'Social Functioning at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '52', 'spread': '16', 'groupId': 'OG000'}, {'value': '55', 'spread': '17', 'groupId': 'OG001'}, {'value': '53', 'spread': '20', 'groupId': 'OG002'}, {'value': '78', 'spread': '26', 'groupId': 'OG003'}, {'value': '84', 'spread': '25', 'groupId': 'OG004'}]}]}, {'title': 'Pain at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '23', 'groupId': 'OG000'}, {'value': '69', 'spread': '27', 'groupId': 'OG001'}, {'value': '78', 'spread': '26', 'groupId': 'OG002'}, {'value': '73', 'spread': '26', 'groupId': 'OG003'}, {'value': '80', 'spread': '29', 'groupId': 'OG004'}]}]}, {'title': 'General Health at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '46', 'spread': '16', 'groupId': 'OG000'}, {'value': '48', 'spread': '14', 'groupId': 'OG001'}, {'value': '48', 'spread': '18', 'groupId': 'OG002'}, {'value': '65', 'spread': '24', 'groupId': 'OG003'}, {'value': '77', 'spread': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Health-related Quality of Life per the standardized short form 36-item survey \\[SF-36\\]); self-reported groin pain per a Pain Scale.\n\nIt comprises 36 questions which cover eight domains of health:\n\n1. Physical Function (Range 0 to 100)\n2. Social Functioning (Range 0 to 100)\n3. Role Limitations due to physical Health (Range o to 100)\n4. Pain (Range 0 to 100)\n5. Mental Health (Range 0 to 100)\n6. Role limitations due to emotional health (Range 0 to 100)\n7. Energy and fatigue (Range 0 to 100)\n8. General health (Range 0 to 100)\n\nEach scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'SECONDARY', 'title': 'Clinical Utility Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll-in)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'ICU Length of Stay, hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '38', 'groupId': 'OG000'}, {'value': '26', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '31', 'spread': '15', 'groupId': 'OG002'}, {'value': '33', 'spread': '11', 'groupId': 'OG003'}, {'value': '12', 'spread': '25', 'groupId': 'OG004'}]}]}, {'title': 'Time to Ambulation, hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'spread': '16', 'groupId': 'OG000'}, {'value': '17', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '16', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '22', 'spread': '13', 'groupId': 'OG003'}, {'value': '19', 'spread': '14', 'groupId': 'OG004'}]}]}, {'title': 'Time to Normal Diet, hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'spread': '22', 'groupId': 'OG000'}, {'value': '14', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '10', 'spread': '8.4', 'groupId': 'OG002'}, {'value': '17', 'spread': '7.4', 'groupId': 'OG003'}, {'value': '18', 'spread': '11', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Procedure to Discharge Visit', 'description': 'In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'SECONDARY', 'title': 'Clinical Utility Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll-in)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'Foley Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}]}, {'title': 'Central Venous Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Nasogastric Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Discharged to SNF/ALF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Procedure to Discharge Visit', 'description': '% requiring Foley catheter, central venous catheter, or gastric tube; % discharged to skilled nursing facility (SNFs) or assistive living facility (ALFs); % requiring analgesic for groin pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Non-serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll-in)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'General disorders and administration site conditions', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Surgical and medical procedures', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Utility Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll -In)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll -In)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'spread': '90', 'groupId': 'OG000'}, {'value': '120', 'spread': '78', 'groupId': 'OG001'}, {'value': '123', 'spread': '56', 'groupId': 'OG002'}, {'value': '157', 'spread': '94', 'groupId': 'OG003'}, {'value': '118', 'spread': '54', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through Pre-Discharge Visit', 'description': 'In-hospital evaluations: Contrast media volume used', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Utility Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll -In)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll -In)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'Anesthesia Time, min', 'categories': [{'measurements': [{'value': '203', 'spread': '93', 'groupId': 'OG000'}, {'value': '181', 'spread': '65', 'groupId': 'OG001'}, {'value': '152', 'spread': '56', 'groupId': 'OG002'}, {'value': '201', 'spread': '75', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '1.28', 'groupId': 'OG004'}]}]}, {'title': 'Fluoroscopy Time, min', 'categories': [{'measurements': [{'value': '24', 'spread': '14', 'groupId': 'OG000'}, {'value': '26', 'spread': '16', 'groupId': 'OG001'}, {'value': '22', 'spread': '8.5', 'groupId': 'OG002'}, {'value': '30', 'spread': '16', 'groupId': 'OG003'}, {'value': '25', 'spread': '13', 'groupId': 'OG004'}]}]}, {'title': 'Ipsilateral Time to Hemostasis, min', 'categories': [{'measurements': [{'value': '23', 'spread': '23', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '17', 'groupId': 'OG001'}, {'value': '13', 'spread': '19', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '6.8', 'groupId': 'OG003'}, {'value': '5.6', 'spread': '6.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Procedure', 'description': 'In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.', 'unitOfMeasure': 'Min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'SECONDARY', 'title': 'Clinical Utility Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'OG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'OG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'OG003', 'title': 'PEVAR (ProGlide Roll-in)', 'description': 'PEVAR performed with the ProGlide suture mediated closure system.'}, {'id': 'OG004', 'title': 'PEVAR (Prostar XL Roll-in)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}], 'classes': [{'title': 'EligibleTime to Hospital Discharge, days', 'categories': [{'measurements': [{'value': '1.76', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': 'Actual Time to Hospital Discharge, days', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through Pre-Discharge Visit', 'description': 'In-hospital evaluations: Times to possible and actual hospital discharge.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access\n\nSEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR'}, {'id': 'FG001', 'title': 'PEVAR (ProGlide Closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}, {'id': 'FG002', 'title': 'PEVAR (ProstarXL Closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'FG003', 'title': 'PEVAR (Prostar XL Roll-In Phase)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device\n\nPEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device'}, {'id': 'FG004', 'title': 'PEVAR (ProGlide Roll-In Phase)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device\n\nPEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '41 Roll-in patients were entered in the study. 151 patients were randomized to either PEVAR ProGlide, PEVAR Prostar XL or SEVAR treatment for AAA repair. The enrollment period was from July 15, 2010 to February 9, 2012. The final patient completed the study in September 2012.', 'preAssignmentDetails': '151 Randomized patients and 41 Roll-in patients were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '192', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'SEVAR', 'description': 'Standard vascular exposure cutdown approach (SEVAR=Control).'}, {'id': 'BG001', 'title': 'PEVAR Perclose ProGlide', 'description': 'PEVAR performed with the Perclose ProGlide suture mediated closure system.'}, {'id': 'BG002', 'title': 'PEVAR Prostar XL', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}, {'id': 'BG003', 'title': 'PEVAR (Prostar XL Roll -In)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}, {'id': 'BG004', 'title': 'PEVAR (ProGlide Roll -In)', 'description': 'PEVAR performed with the Prostar XL suture mediated closure system.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '70', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '74', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '73', 'spread': '7.0', 'groupId': 'BG003'}, {'value': '71', 'spread': '6.9', 'groupId': 'BG004'}, {'value': '72.2', 'spread': '7.98', 'groupId': 'BG005'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '175', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '172', 'groupId': 'BG005'}]}]}, {'title': 'Non-white', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '151', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '29', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '28', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '27', 'spread': '4.4', 'groupId': 'BG003'}, {'value': '29', 'spread': '5.8', 'groupId': 'BG004'}, {'value': '28.2', 'spread': '4.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2012-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2010-02-16', 'resultsFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-06', 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).', 'timeFrame': '30 days', 'description': 'The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator:\n\n* Procedural technical success\n* Absence of vascular complication\n* Absence of major adverse event'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '30 days', 'description': 'SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).'}, {'measure': 'SF-36 (Health-related Quality of Life Survey)', 'timeFrame': '30 days', 'description': 'Health-related Quality of Life per the standardized short form 36-item survey \\[SF-36\\]); self-reported groin pain per a Pain Scale.\n\nIt comprises 36 questions which cover eight domains of health:\n\n1. Physical Function (Range 0 to 100)\n2. Social Functioning (Range 0 to 100)\n3. Role Limitations due to physical Health (Range o to 100)\n4. Pain (Range 0 to 100)\n5. Mental Health (Range 0 to 100)\n6. Role limitations due to emotional health (Range 0 to 100)\n7. Energy and fatigue (Range 0 to 100)\n8. General health (Range 0 to 100)\n\nEach scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}, {'measure': 'Clinical Utility Measures', 'timeFrame': 'From Procedure to Discharge Visit', 'description': 'In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.'}, {'measure': 'Clinical Utility Measures', 'timeFrame': 'From Procedure to Discharge Visit', 'description': '% requiring Foley catheter, central venous catheter, or gastric tube; % discharged to skilled nursing facility (SNFs) or assistive living facility (ALFs); % requiring analgesic for groin pain.'}, {'measure': 'Number of Participants With All Non-serious Adverse Events', 'timeFrame': '30 Days', 'description': 'Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.'}, {'measure': 'Clinical Utility Measure', 'timeFrame': 'Through Pre-Discharge Visit', 'description': 'In-hospital evaluations: Contrast media volume used'}, {'measure': 'Clinical Utility Measures', 'timeFrame': 'During Procedure', 'description': 'In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.'}, {'measure': 'Clinical Utility Measures', 'timeFrame': 'Through Pre-Discharge Visit', 'description': 'In-hospital evaluations: Times to possible and actual hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous', 'Preclose', 'Endologix', 'Abbott Vascular', 'Endovascular', 'PEVAR', 'Stent graft', 'Suture mediated closure devices'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '36629152', 'type': 'DERIVED', 'citation': 'Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev. 2023 Jan 11;1(1):CD010185. doi: 10.1002/14651858.CD010185.pub4.'}, {'pmid': '24440678', 'type': 'DERIVED', 'citation': 'Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.'}, {'pmid': '21796092', 'type': 'DERIVED', 'citation': 'Krajcer Z, Nelson P, Bianchi C, Rao V, Morasch M, Bacharach J. Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial. J Cardiovasc Surg (Torino). 2011 Oct;52(5):651-9. Epub 2011 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and effectiveness of PEVAR.', 'detailedDescription': 'In \\>30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.\n\nThe IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.\n\nPatients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Informed consent form understood and signed and patient agrees to all follow-up visits\n* Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months\n* Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol\n* Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)\n\nExclusion Criteria:\n\n* Life expectancy \\<1 year as judged by the investigator;\n* Psychiatric or other condition that may interfere with the study;\n* Participating in the enrollment or 30-day follow-up phase of another clinical study;\n* Known allergy to any device component;\n* Coagulopathy or uncontrolled bleeding disorder;\n* Ruptured, leaking, or mycotic aneurysm;\n* Serum creatinine (S-Cr) level \\>1.7 mg/dL;\n* Traumatic vascular injury;\n* Active systemic or localized groin infection;\n* Connective tissue disease (e.g., Marfan's Syndrome);\n* Renal transplant patient;\n* Recent (within prior three months) cerebrovascular accident or myocardial infarction;\n* Planned major intervention or surgery within 30 days following the EVAR procedure;\n* Requirement for an arterial conduit at the access site;\n* Morbidly obese (BMI≥40);\n* Calcification throughout the common femoral artery (CFA) target area anterior wall or circumferentially or over \\>50% of the posterior wall;\n* Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;\n* Evidence of prior common femoral artery surgery (e.g., groin incision);\n* Prior clip-based vascular closure device placement in either arterial access site;\n* Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;\n* Femoral artery needle puncture in either arterial access site within the prior 30 days;\n* Hematoma at the ipsilateral arterial access site\n* Significant scarring at the ipsilateral arterial access site"}, 'identificationModule': {'nctId': 'NCT01070069', 'acronym': 'PEVAR', 'briefTitle': 'Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endologix'}, 'officialTitle': 'Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System', 'orgStudyIdInfo': {'id': 'CP-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard EVAR (IntuiTrak)', 'description': 'EVAR using standard vascular exposure for access', 'interventionNames': ['Device: SEVAR (IntuiTrak)']}, {'type': 'EXPERIMENTAL', 'label': 'PEVAR (ProGlide closure)', 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device', 'interventionNames': ['Device: PEVAR (ProGlide closure)']}, {'type': 'EXPERIMENTAL', 'label': 'PEVAR (ProstarXL closure)', 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device', 'interventionNames': ['Device: PEVAR (Prostar XL closure)']}], 'interventions': [{'name': 'PEVAR (ProGlide closure)', 'type': 'DEVICE', 'otherNames': ['IntuiTrak', 'ProGlide'], 'description': 'Percutaneous EVAR facilitated by the ProGlide closure device', 'armGroupLabels': ['PEVAR (ProGlide closure)']}, {'name': 'SEVAR (IntuiTrak)', 'type': 'DEVICE', 'otherNames': ['IntuiTrak'], 'description': 'Standard vascular exposure for access prior to EVAR', 'armGroupLabels': ['Standard EVAR (IntuiTrak)']}, {'name': 'PEVAR (Prostar XL closure)', 'type': 'DEVICE', 'otherNames': ['IntuiTrak', 'Prostar XL'], 'description': 'Percutaneous EVAR facilitated by the Prostar XL closure device', 'armGroupLabels': ['PEVAR (ProstarXL closure)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda VA Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Forrest General Hospital', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44094', 'city': 'Willoughby', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake Health', 'geoPoint': {'lat': 41.63977, 'lon': -81.4065}}, {'zip': '93120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'North Central Heart Hospital', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Hospital at Texas Heart Institute", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Edward B Diethrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endologix'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endologix', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}