Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT05055102
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and security', 'timeFrame': '5 years', 'description': 'Occurrence of death or major re-intervention (bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation) over the entire follow-up period (from date of surgery to study end date (February 28, 2021))'}], 'secondaryOutcomes': [{'measure': 'Major surgical reintervention', 'timeFrame': '5 years', 'description': 'bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation throughout the follow-up period'}, {'measure': 'Primary permeability', 'timeFrame': '5 years', 'description': 'Stenosis/thrombosis of the prosthesis over the entire follow-up period'}, {'measure': 'Secondary permeability', 'timeFrame': '5 years', 'description': 'Stenosis/thrombosis after reintervention over the entire follow-up period'}, {'measure': 'Dilatation of the prothesis', 'timeFrame': '5 years', 'description': 'Diameter of the prosthesis over the entire follow-up period'}, {'measure': 'Occurence of MAVE and MACE', 'timeFrame': '5 years', 'description': 'Occurence of MAVE and MACCE (re-interventions, ischemic cardiac, neurological (stroke/TIA), pulmonary and renal complications) throughout the follow-up period'}, {'measure': 'Occurence of adverse events', 'timeFrame': '5 years', 'description': 'Other adverse events over the entire follox-up period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysms or Occlusive Disease of the Abdominal Aorta']}, 'descriptionModule': {'briefSummary': 'The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.\n\nWe purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).\n\nThe objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is volontarily agree to participation\n* Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society\n\nExclusion Criteria:\n\n\\- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data'}, 'identificationModule': {'nctId': 'NCT05055102', 'acronym': 'WOBIF', 'briefTitle': 'Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta', 'orgStudyIdInfo': {'id': 'STEINMETZ LEMAITRE 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with WOVEX bifurcated prosthesis', 'description': '* Patients who have undergone open abdominal aortic surgery between January 1st, 2013 and December 31, 2017 in Burgundy Dijon Hospital.\n* Patients who have been treated with a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses)', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'demographics co-morbidities risk factors operative, hospital and vascular follow-up data', 'armGroupLabels': ['Patient with WOVEX bifurcated prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}