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.

NCT ID: NCT05055102

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-16
• Study Completion Date: 2021-08-31

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.

Conditions

Aneurysms or Occlusive Disease of the Abdominal Aorta

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patient with WOVEX bifurcated prosthesis

• 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)

Data collection

Intervention Type: OTHER

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

Interventions

Data collection

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

STEINMETZ LEMAITRE 2020

Identifier Type: -

Identifier Source: org_study_id