Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00520416
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2007-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2007-08-22', 'studyFirstSubmitQcDate': '2007-08-22', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-24', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbon Dioxide', 'Endovascular Abdominal Aortic Aneurym Repair', 'Prospective', 'Angiogram']}, 'descriptionModule': {'briefSummary': 'Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas contrast is given as an extra step. The images will be later evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infrarenal abdominal aortic aneurysm amendable to endovascular repair\n\nExclusion Criteria:\n\n* renal failure or contraindication to receiving iodine contrast.'}, 'identificationModule': {'nctId': 'NCT00520416', 'briefTitle': 'Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'orgStudyIdInfo': {'id': 'HS-06-00263'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'There is no control or experimental group. The same patients undergoing endovascular AAA repair with serve as their own control', 'interventionNames': ['Procedure: Carbon dioxide angiogram']}], 'interventions': [{'name': 'Carbon dioxide angiogram', 'type': 'PROCEDURE', 'description': 'see description of procedure', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC University Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Fred A Weaver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}