Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-30 @ 2:43 AM
Study NCT ID:
NCT06786351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Right Atrial Occlusion on TEVAR Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoleak occurrence up to hospital discharge', 'timeFrame': 'end of surgery to hospital discharge up to 10 days)', 'description': 'Endoleak occurrence prior to hospital discharge'}, {'measure': 'Endoleak occurrence to one-year post-surgery', 'timeFrame': 'end of surgery to one-year post-surgery', 'description': 'Endoleak occurrence within one-year of surgery'}], 'secondaryOutcomes': [{'measure': 'Perioperative mortality to 30 days post-surgery', 'timeFrame': 'post-surgery to 30 days post-surgery', 'description': '30-day perioperative mortality'}, {'measure': 'All-cause mortality to one-year post-surgery', 'timeFrame': 'post-surgery to one-year post-surgery', 'description': 'One-year all-cause mortality'}, {'measure': 'Complications: massive hemorrhage', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of massive hemorrhage'}, {'measure': 'Complications: cerebrovascular', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of cerebrovascular accident/transient ischemic attack'}, {'measure': 'Complications: spinal cord ischemia', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of spinal cord ischemia'}, {'measure': 'Complications: iliofemoral access', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of iliofemoral access complications (bleeding/infection/thrombosis)'}, {'measure': 'Complications: retrograde dissection', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of retrograde dissection'}, {'measure': 'Complications: prolonged ventilation', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of prolonged ventilation for more than 24 hours'}, {'measure': 'Complications: acute kidney injury', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of acute kidney injury'}, {'measure': 'Complications: acute kidney injury with renal replacement therapy', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of acute kidney injury requiring renal replacement therapy'}, {'measure': 'Complications: cardiovascular events', 'timeFrame': 'within 30 days post-surgery and at 1 year', 'description': 'Occurrence of cardiovascular events (myocardial injury after non-cardiac surgery/cardiac arrest/myocardial infarction)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['right atrial balloon occlusion', 'thoracic endovascular aortic repair', 'stent graft repair', 'reduction of elimination of aortic impulse'], 'conditions': ['Thoracic Aortic Aneurysm', 'Thoracic Aortic Dissection', 'Thoracic Aorta Abnormality']}, 'descriptionModule': {'briefSummary': 'Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* thoracic endovascular aortic repair\n* right atrial balloon occlusion for reduction or elimination of aortic impulse\n* endograft deployment in landing zones 0-3\n\nExclusion Criteria:\n\n* age 18 years or younger\n* non-thoracic endovascular aortic repair\n* reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion\n* endograft deployment in landing zones 4 and beyond'}, 'identificationModule': {'nctId': 'NCT06786351', 'briefTitle': 'Impact of Right Atrial Occlusion on TEVAR Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Impact of Right Atrial Occlusion on TEVAR Outcomes: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'REB24-1367'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right atrial balloon occlusion', 'description': 'Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse', 'interventionNames': ['Procedure: Right atrial balloon occlusion']}, {'label': 'Non right atrial balloon occlusion', 'description': 'Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse', 'interventionNames': ['Procedure: Non right atrial balloon occlusion']}], 'interventions': [{'name': 'Right atrial balloon occlusion', 'type': 'PROCEDURE', 'description': 'Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3', 'armGroupLabels': ['Right atrial balloon occlusion']}, {'name': 'Non right atrial balloon occlusion', 'type': 'PROCEDURE', 'description': 'Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3', 'armGroupLabels': ['Non right atrial balloon occlusion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Claire Allen, MD, FRCPC', 'role': 'CONTACT', 'email': 'claire.allen@ahs.ca', 'phone': '403-'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer', 'investigatorFullName': 'Claire Allen', 'investigatorAffiliation': 'University of Calgary'}}}}