Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06187051
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2023-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094682', 'term': 'Endovascular Aneurysm Repair'}, {'id': 'D020878', 'term': 'Device Removal'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019917', 'term': 'Blood Vessel Prosthesis Implantation'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-29', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative mortality', 'timeFrame': 'day 30 post operative', 'description': 'Patient death after the treatment of type 1A endoleak'}, {'measure': 'Major adverse cardiovascular event (MACE) post operative', 'timeFrame': 'day 30 post operative', 'description': 'Patient presenting after surgery a composite score (MACE) including\n\n* nonfatal stroke,\n* nonfatal myocardial infarction\n* cardiovascular death'}, {'measure': 'Redo surgery after type 1A endoleak surgery', 'timeFrame': '30 day, 6 months, 12 months, 24 months', 'description': 'Reintervention after FEVAR or explantation surgery'}], 'secondaryOutcomes': [{'measure': 'Efficiency of the treatment', 'timeFrame': '30 day, 6 months, 12 months, 24 months', 'description': 'No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aorta Aneurysm']}, 'descriptionModule': {'briefSummary': 'Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.\n\nA retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presenting a type 1A endoleak after EVAR for AAA during the follow up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1A endoleak after EVAR\n\nExclusion Criteria:\n\n* no'}, 'identificationModule': {'nctId': 'NCT06187051', 'briefTitle': "Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best", 'organization': {'class': 'OTHER', 'fullName': 'University Paul Sabatier of Toulouse'}, 'officialTitle': 'FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study', 'orgStudyIdInfo': {'id': 'Type 1 endoleak : FEVAR vs OSR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR', 'interventionNames': ['Device: FEVAR']}, {'label': 'Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR', 'interventionNames': ['Device: Explantation']}], 'interventions': [{'name': 'FEVAR', 'type': 'DEVICE', 'description': 'Relining the EVAR with FEVAR', 'armGroupLabels': ['Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR']}, {'name': 'Explantation', 'type': 'DEVICE', 'description': 'open surgery to explant the previous EVAR', 'armGroupLabels': ['Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Paul Sabatier of Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Aurélien Hostalrich', 'investigatorAffiliation': 'University Paul Sabatier of Toulouse'}}}}