Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 1:52 PM
Study NCT ID:
NCT03713450
Status:
TERMINATED
Last Update Posted:
2023-05-23
First Post:
2018-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2018-10-18', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose area product', 'timeFrame': 'The end of the procedure', 'description': 'Dose area product (DAP) by the end of the procedure.'}], 'secondaryOutcomes': [{'measure': 'Number of DSA runs', 'timeFrame': 'The end of the procedure', 'description': 'Number of DSA runs by the end of the procedure.'}, {'measure': 'Air Kerma', 'timeFrame': 'The end of the procedure', 'description': 'Air Kerma (mGy) by the end of the procedure.'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'The end of the procedure', 'description': 'Fluoroscopy time (min) by the end of the procedure.'}, {'measure': 'Contrast volume', 'timeFrame': 'The end of the procedure', 'description': 'Contrast volume (ml) by the end of the procedure.'}, {'measure': 'Operative time', 'timeFrame': 'The end of the procedure', 'description': 'Operative time (min) by the end of the procedure.'}, {'measure': 'Operator exposure', 'timeFrame': 'The end of the procedure', 'description': 'Operator exposure (Sv) by the end of the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation', 'Contrast', 'Endovascular', 'Fusion imaging guidance', 'Iliac'], 'conditions': ['Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization']}, 'descriptionModule': {'briefSummary': "Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.\n\nOne way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.\n\nThis advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.\n\nThis trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 or older,\n* Patients scheduled for aorto iliac endovascular revascularisation,\n* Pre-operative CT scan.\n\nExclusion Criteria:\n\n* Women of childbearing age,\n* Absence of preoperative CT scan,\n* Emergency procedures.'}, 'identificationModule': {'nctId': 'NCT03713450', 'acronym': 'CYDAR ILIAC', 'briefTitle': 'Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls', 'orgStudyIdInfo': {'id': 'RC18_0092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control with imaging guidance', 'interventionNames': ['Device: Control with imaging guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control without imaging guidance', 'interventionNames': ['Device: Control without imaging guidance']}], 'interventions': [{'name': 'Control with imaging guidance', 'type': 'DEVICE', 'description': 'Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.\n\nThe study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).', 'armGroupLabels': ['Control with imaging guidance']}, {'name': 'Control without imaging guidance', 'type': 'DEVICE', 'description': 'Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.\n\nThe study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).', 'armGroupLabels': ['Control without imaging guidance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital, Vascular surgery, Institut du Thorax', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}