Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-31 @ 9:56 AM
Study NCT ID:
NCT06972095
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-20', 'releaseDate': '2025-08-04'}], 'estimatedResultsFirstSubmitDate': '2025-08-04'}}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from reinterventions at one year', 'timeFrame': 'one year', 'description': 'reintervention-free survival will be evaulated using kaplan meier method'}], 'secondaryOutcomes': [{'measure': 'Freedom from reinterventions throughout follow-up (up to ten years)', 'timeFrame': '10 years', 'description': 'Reintervention-free survival throughout all available follow-up will be evaluated using kaplan-meier methods'}, {'measure': 'Number of endoleaks', 'timeFrame': '10 year follow-up', 'description': 'All endoleaks will be registered throughout follow-up and will be presented by type of endoleak.'}, {'measure': 'the number of patients showing aneurysm sac growth', 'timeFrame': '10 year follow-up', 'description': 'Sac growth is defined as growth over 5 mm and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up'}, {'measure': 'the number of patients with an aneurysm rupture during follow-up', 'timeFrame': '10 year follow-up', 'description': 'all ruptures that occur will be registered including outcome (death or successful repair)'}, {'measure': 'the number of patients showing stent migration', 'timeFrame': '10 year follow-up', 'description': 'stent migration will be documented in mm and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up'}, {'measure': 'Number of patients with AAA related mortality', 'timeFrame': '10 year follow-up', 'description': 'All deaths related to the AAA will be documented'}, {'measure': 'the number of patients showing proximal fixation failure', 'timeFrame': '10 year follow-up', 'description': 'proximal fixation failure is defined as yes if type 1 endoleak or stent migration or aneurysm sac growth will occur and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up'}, {'measure': 'All-cause mortality', 'timeFrame': '10 year follow-up', 'description': 'all deaths will be registered regardless their cause'}, {'measure': 'The number of patients with 30-day complications', 'timeFrame': '30 days', 'description': 'All complications during the first 30 days will be registered related to the procedure and will be listed for the different types of complications'}, {'measure': 'The number of patients with renal dysfunction/renal occlusion', 'timeFrame': '10 year follow-up', 'description': 'all clinical relevant declines in renal function will be documented, including renal artery stenosis or occlusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal aortic aneurysm', 'EVAR', 'wide neck', 'conical neck', 'hostile neck'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.', 'detailedDescription': 'Objective: To evaluate the performance of the Endurant endoprothesis in patients with a wide or conical shaped neck anatomy after elective abdominal aortic aneurysm repair.\n\nInclusion: Patients who underwent elective infrarenal abdominal aortic aneurysm repair with the Endurant endograft between January 2011 until January 2020 in Rijnstate, Arnhem, the Netherlands.\n\nPrimary endpoint: Freedom from reinterventions at one year.\n\nSecondary outcomes:\n\n* Endoleaks\n* Aneurysm sac growth\n* Aneurysm rupture\n* Stent migration\n* AAA-related mortality\n* All-cause mortality\n* Procedural time\n* 30-day complications\n* Renal dysfunction/renal occlusion\n* Proximal fixation failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the Endurant endoprothesis between January 2011 till January 2020 in the Rijnstate hospital, Arnhem, the Netherlands.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the Endurant endoprothesis between January 2011 till January 2020 in the Rijnstate hospital, Arnhem, the Netherlands.\n\nExclusion Criteria:\n\n* emergency/rupture procedures\n* objection use of data for research\n* other prosthesis used for EVAR'}, 'identificationModule': {'nctId': 'NCT06972095', 'acronym': 'Endurant_WCN', 'briefTitle': 'The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy', 'orgStudyIdInfo': {'id': '2021-1830'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wide neck group', 'description': 'patients with an abdominal aortic aneurysm and a wide neck (\\>28 mm diameter)', 'interventionNames': ['Procedure: EVAR']}, {'label': 'conical neck group', 'description': 'patients with an abdominal aortic aneurysm and a conical neck', 'interventionNames': ['Procedure: EVAR']}, {'label': 'straight neck group', 'description': 'patients with an abdominal aortic aneurysm without a wide or conical neck', 'interventionNames': ['Procedure: EVAR']}], 'interventions': [{'name': 'EVAR', 'type': 'PROCEDURE', 'description': 'endovascular repair of the AAA with the endurant stent graft', 'armGroupLabels': ['Wide neck group', 'conical neck group', 'straight neck group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6515AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'On request we can decide if data can be shared; due to country and hospital policy, data transfer agreements need to be in place'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-04', 'type': 'RELEASE'}, {'date': '2025-08-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rijnstate Hospital'}}}}