Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT04721951
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': '30 Days', 'description': 'Technical success to assess the renal ostia and the hypogastric arteries (defined as 100% accuracy correlated to the iodinated contrast agent angiography or IVUS/FUSION techniques)'}], 'secondaryOutcomes': [{'measure': 'Image Quality', 'timeFrame': '30 Days', 'description': 'Image quality for guiding the procedure defined as good for stent-graft implantation or low not allowing stent-graft implantation'}, {'measure': 'Endoleak Detection', 'timeFrame': '30 Days', 'description': 'Type I-IV endoleak detection'}, {'measure': 'CO2 Quantity', 'timeFrame': '30 Days', 'description': 'Amount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)'}, {'measure': 'Aneurysm Exclusion', 'timeFrame': '30 Days', 'description': 'Aneurysm exclusion without type I or III endoleaks at the CT scan at discharge'}, {'measure': 'Adverse Events', 'timeFrame': '30 Days', 'description': 'Any adverse event within 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovascular Aortic Repair'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with AAA, undergoing EVAR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Male, female\n* Patients with indication for AAA\n* Informed consent achievement\n\nExclusion Criteria:\n\n* Severe COPD (Chronic Obstructive Pulmonary Disease)\n* Known atrium- or ventricular septal defect with right-left-shunt\n* Severe renal arteries atherosclerosis\n* Ruptured AAA\n* Current partecipation in other interventional studies'}, 'identificationModule': {'nctId': 'NCT04721951', 'acronym': 'CO2-EVAR', 'briefTitle': 'An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)', 'orgStudyIdInfo': {'id': 'CO2-EVAR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endovascular Aortic Repair using Carbon Dioxide Angiography', 'type': 'PROCEDURE', 'description': 'Endovascular Aortic Repair using Carbon Dioxide Angiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Department of experimental diagnostic and specialty medicine - Vascular Surgery', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Mauro Gargiulo, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Vacirca', 'investigatorAffiliation': 'University of Bologna'}}}}