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.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05055102

Acronym

WOBIF

Enrollment

173

Registered

2021-09-24

Start date

2021-01-16

Completion date

2021-08-31

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysms or Occlusive Disease of the Abdominal Aorta

Brief summary

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. We 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). The 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.

Interventions

OTHERData collection

demographics co-morbidities risk factors operative, hospital and vascular follow-up data

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is volontarily agree to participation * 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

Exclusion criteria

\- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data

Design outcomes

Primary

Measure	Time frame	Description
Safety and security	5 years	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))

Secondary

Measure	Time frame	Description
Secondary permeability	5 years	Stenosis/thrombosis after reintervention over the entire follow-up period
Major surgical reintervention	5 years	bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation throughout the follow-up period
Dilatation of the prothesis	5 years	Diameter of the prosthesis over the entire follow-up period
Occurence of MAVE and MACE	5 years	Occurence of MAVE and MACCE (re-interventions, ischemic cardiac, neurological (stroke/TIA), pulmonary and renal complications) throughout the follow-up period
Occurence of adverse events	5 years	Other adverse events over the entire follox-up period
Primary permeability	5 years	Stenosis/thrombosis of the prosthesis over the entire follow-up period

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026