Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05414318
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2022-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D000094629', 'term': 'Dissection, Thoracic Aorta'}], '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'}, {'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'crobe@wlgore.com', 'phone': '928-864-4048', 'title': 'Charee Robe', 'organization': 'W.L. Gore & Associates'}, 'certainAgreement': {'otherDetails': 'The PI is required to obtain written permission from the Sponsor prior to publishing trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years (Post-operative day 0-2006)', 'eventGroups': [{'id': 'EG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 10, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Trauma', 'description': 'Traumatic thoracic aortic injury', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Aortic Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'False Lumen Enlargement (>=5mm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelactasis/Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Bowel Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraplegia/Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prosthesis Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Complications (not device complication)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endoleak Type Ia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endoleak Type III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endoleak, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Entry Tear Exclusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Number of subjects who achieved the primary entry tear exclusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with acute complicated Stanford type B dissection with evaluable result. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)'}, {'type': 'PRIMARY', 'title': 'Aortic Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure through 5 years (Day 0-2006)', 'description': 'Number of subjects with Aortic Rupture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with acute complicated Stanford type B dissection. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)'}, {'type': 'PRIMARY', 'title': 'Major Device-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}, {'id': 'OG001', 'title': 'Trauma', 'description': 'Traumatic thoracic aortic injury'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure through 5 years (Day 0-2006)', 'description': 'Number of subjects with major device-related adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Secondary Intervention Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}, {'id': 'OG001', 'title': 'Trauma', 'description': 'Traumatic thoracic aortic injury'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-procedure through 5 years (Day 1-2006)', 'description': 'Incidence rate of secondary intervention treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Minimum True Lumen Diameter Adjacent to Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with acute complicated Stanford type B dissection with evaluable result. (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)'}, {'type': 'PRIMARY', 'title': 'Change in Minimum True Lumen Diameter Distal to Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in minimum true lumen diameter distal to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)'}, {'type': 'PRIMARY', 'title': 'Change in Maximum False Lumen Diameter Adjacent to Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dissection', 'description': 'Acute complicated Stanford type B dissection'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Decrease', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - 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'2024-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-27', 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Entry Tear Exclusion', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Number of subjects who achieved the primary entry tear exclusion'}, {'measure': 'Aortic Rupture', 'timeFrame': 'Procedure through 5 years (Day 0-2006)', 'description': 'Number of subjects with Aortic Rupture'}, {'measure': 'Major Device-related Adverse Events', 'timeFrame': 'Procedure through 5 years (Day 0-2006)', 'description': 'Number of subjects with major device-related adverse events'}, {'measure': 'Secondary Intervention Treatment', 'timeFrame': 'Post-procedure through 5 years (Day 1-2006)', 'description': 'Incidence rate of secondary intervention treatment'}, {'measure': 'Change in Minimum True Lumen Diameter Adjacent to Treated Segment', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)'}, {'measure': 'Change in Minimum True Lumen Diameter Distal to Treated Segment', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in minimum true lumen diameter distal to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)'}, {'measure': 'Change in Maximum False Lumen Diameter Adjacent to Treated Segment', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)'}, {'measure': 'Change in Maximum False Lumen Diameter Distal to Treated Segment', 'timeFrame': 'At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in maximum false lumen diameter distal to treated segment at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)'}, {'measure': 'Change in Maximum Lesion Diameter', 'timeFrame': 'At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)', 'description': 'Change in maximum lesion diameter at each follow-up visit:\n\nDecrease (\\>=5mm) vs No change vs Increase (\\>=5mm)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Thoracic Aortic Aneurysm', 'Thoracic Aorta Injury', 'Thoracic Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute, complicated Stanford Type B aortic dissection and patients with traumatic aortic transection treated using Gore CTAG.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection:\n\n* Patient present with acute complicated type B aortic dissection\n* Patient who do not respond to medical therapy\n* Time from symptom onset to dissection diagnosis ≤ 14 days\n* Adequate iliac / femoral access or conduit\n* Aortic inner diameter at proximal extent of proximal landing zone in the range of 16-42 mm\n* ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected\n\nInclusion Criteria for Traumatic Aortic Transection:\n\n* Patient has traumatic aortic transection that requires repair as determined by treating physician\n* Adequate iliac / femoral access\n* Aortic inner diameter in the range of 16-42 mm on the proximal and distal sides\n* ≥ 20 mm non-aneurysmal aorta neck proximal and distal to the lesion'}, 'identificationModule': {'nctId': 'NCT05414318', 'briefTitle': 'CTAG Dissection/Trauma Post Marketing Surveillance Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)', 'orgStudyIdInfo': {'id': 'JPS 16-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Conformable GORE® TAG® Thoracic Endoprosthesis', 'type': 'DEVICE', 'description': 'Thoracic Endoprosthesis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}