Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT07149805
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery Benefits Takayasu Arteritis With Stenosis in the Descending Aorta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013625', 'term': 'Takayasu Arteritis'}], 'ancestors': [{'id': 'D001015', 'term': 'Aortic Arch Syndromes'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality rate', 'timeFrame': 'Patients underwent follow-up from discharge until study termination (3 years to 11 years) or death, whichever came first'}, {'measure': 'all-cause mortality rate', 'timeFrame': 'Patients underwent follow-up from discharge (3 years to 11 years) until study termination or death, whichever came first'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Takayasu Arteritis']}, 'descriptionModule': {'briefSummary': 'The long-term prognosis and optimal management for Takayasu arteritis(TA) patients with severe stenosis of the descending thoracic and abdominal aorta remain undefined. We want to compare the clinical outcomes of surgical intervention and medical management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'inpatients at Peking Union Medical College Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. fulfilling the 1990 American College of Rheumatology criteria for the diagnosis of TA;\n2. having at least one site with severe narrowing in the descending thoracic and abdominal aorta;\n3. having symptoms caused by TA-related stenosis, such as uncontrolled hypertension, heart failure, renal ischemia, dizziness, visual disturbances, and claudication\n\nExclusion Criteria:\n\nPatients with arterial stenosis due to other reasons (such as typical atherosclerosis, congenital coarctation of the aorta, and anatomical abnormality) were excluded'}, 'identificationModule': {'nctId': 'NCT07149805', 'briefTitle': 'Surgery Benefits Takayasu Arteritis With Stenosis in the Descending Aorta', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Surgery Improves Survival Rate in Patients With Takayasu Arteritis: a Retrospective Observational Study', 'orgStudyIdInfo': {'id': '2022-PUMCH-A-191'}, 'secondaryIdInfos': [{'id': 'BJZQ2024001', 'type': 'OTHER_GRANT', 'domain': 'The Education Committee of Beijing'}, {'id': 'UBJ06532', 'type': 'OTHER_GRANT', 'domain': "National Health Commission of the People's Republic of China"}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'surgerical group', 'description': 'Patients who underwent surgical treatment', 'interventionNames': ['Procedure: open surgery or interventional treatment']}, {'label': 'conservative group', 'description': 'Patients who underwent conservative treatment'}], 'interventions': [{'name': 'open surgery or interventional treatment', 'type': 'PROCEDURE', 'description': 'open surgery or interventional treatment', 'armGroupLabels': ['surgerical group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'all collected IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yuexin Chen', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}