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.

Completed

• Conditions: Aneurysms or Occlusive Disease of the Abdominal Aorta
• Interventions: Other: Data collection

• Registration Number: NCT05055102
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-16
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with WOVEX bifurcated prosthesis	Data collection	* 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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Major surgical reintervention	5 years	bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation throughout the follow-up period
Primary permeability	5 years	Stenosis/thrombosis of the prosthesis over the entire follow-up period
Dilatation of the prothesis	5 years	Diameter of the prosthesis over the entire follow-up period
Secondary permeability	5 years	Stenosis/thrombosis after reintervention 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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France