Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-24 @ 8:35 AM
Study NCT ID:
NCT00488358
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2007-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-08', 'studyFirstSubmitDate': '2007-06-18', 'studyFirstSubmitQcDate': '2007-06-19', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abdominal', 'aortic', 'aneurysm', 'Zenith', 'blood pressure'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.', 'detailedDescription': 'This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.\n\nAs the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft'}, 'identificationModule': {'nctId': 'NCT00488358', 'briefTitle': 'Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft', 'orgStudyIdInfo': {'id': '10-01645'}}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Division of Vascular Surgery, UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Jade S Hiramoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor in Residence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}