Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT04714268
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2021-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D017543', 'term': 'Iliac Aneurysm'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of contrast product used during the routine care procedure (ml)', 'timeFrame': 'At enrollment', 'description': 'Volume are reported in mL'}, {'measure': 'Irradiation parameters: evaluation of the Fluoroscopy duration (min)', 'timeFrame': 'At enrollment', 'description': 'Parameter given by the X-ray imaging device'}, {'measure': 'Irradiation parameters: dose-area quantification (mGy/m2)', 'timeFrame': 'At enrollment', 'description': 'Parameter given by the X-ray imaging device'}, {'measure': 'Irradiation parameters: measurement of air Kerma (mGy)', 'timeFrame': 'At enrollment', 'description': 'Parameter given by the X-ray imaging device'}], 'secondaryOutcomes': [{'measure': 'Procedure time (min)', 'timeFrame': 'At enrollment', 'description': 'Total procedure time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Aneurysm', 'Iliac Aneurysm', 'Stenoses, Aortic', 'Iliac Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.', 'detailedDescription': 'Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis\n* Suitable for endovascular repair\n* Major patients\n* Patients not opposed to their participation in the study\n\nExclusion Criteria:\n\n* Patients requiring conventional surgical revascularization.'}, 'identificationModule': {'nctId': 'NCT04714268', 'acronym': 'COM-ENDO', 'briefTitle': 'Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Therenva'}, 'officialTitle': 'Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation', 'orgStudyIdInfo': {'id': '002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Procedures with EndoNaut', 'description': 'Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images', 'interventionNames': ['Procedure: Aorto-iliac endovascular procedure']}, {'label': 'Procedures without EndoNaut', 'description': 'Control group, endovascular interventions without 3D image fusion', 'interventionNames': ['Procedure: Aorto-iliac endovascular procedure']}], 'interventions': [{'name': 'Aorto-iliac endovascular procedure', 'type': 'PROCEDURE', 'description': 'Percutaneous procedure with stent placement', 'armGroupLabels': ['Procedures with EndoNaut', 'Procedures without EndoNaut']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adrien Kaladji, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Florent Lalys, PhD', 'role': 'CONTACT', 'email': 'florent.lalys@therenva.com', 'phone': '+33789833846'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therenva', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'Douai hospital', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'University Hospital, Brest', 'class': 'OTHER'}, {'name': 'Polyclinique Bordeaux Nord Aquitaine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}