Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-25 @ 1:48 PM
Study NCT ID:
NCT01022892
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2009-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D057867', 'term': 'Endoleak'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2009-11-26', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endovascular', 'Abdominal', 'Aortic', 'Aneurysm', 'Repair', 'Surveillance', 'EVAR', 'CT', 'Scan', 'Endoleaks', 'Contrast', 'Enhanced', 'Ultrasound', 'Definity', 'AAA', 'imaging', 'No Endoleaks'], 'conditions': ['Endovascular Abdominal Aortic Aneurysm Repair']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.\n\nThe investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent EVAR at The Ottawa Hospital and are currently undergoing post-EVAR surveillance will be eligible for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.\n\nExclusion Criteria:\n\n* Unable to consent for injection of contrast\n* Unable to acquire IV access\n* Right-to-left, bi-directional, or transient right-to-left cardiac shunts\n* Severe pulmonary disease\n* Previous hypersensitivity to DEFINITY® or its components\n* Unable to be followed as a outpatient by the Vascular Diagnostic Center'}, 'identificationModule': {'nctId': 'NCT01022892', 'briefTitle': 'Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair', 'orgStudyIdInfo': {'id': '2007607-01H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1 - Pilot phase', 'description': 'Total of 10 patients currently undergoing EVAR Surveillance. These 10 patients include 5 patients with endoleak known from a recent CT scan and 5 patients with no endoleak and shrinking aneurysm.'}, {'label': 'Phase 2 - Blinded from CT Scan', 'description': 'This phase of study involves recruitment of 150 patients currently under post-EVAR surveillance. The physicians and ultrasound technologists will be blinded to the result of the CT Scan when performing and interpreting the CUS. The current schedule for EVAR Surveillance will be maintained so that an individual may receive more than one enhanced CT Scan and CUS during the 18 months of the study.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sudhir Nagpal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital - Division of Vascular & Endovascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgeon', 'investigatorFullName': 'Dr. Sudhir Nagpal', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}