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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. (WOBIF)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Aneurysms or Occlusive Disease of the Abdominal Aorta

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT05055102
STEINMETZ LEMAITRE 2020

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

173 participants in 1 patient group

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. * Patients who have been treated with a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses)
Treatment:
Other: Data collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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