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)

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

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.

Study Overview

• Status: Completed
• Conditions: Aneurysms or Occlusive Disease of the Abdominal Aorta
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Data collection; demographics co-morbidities risk factors operative, hospital and vascular follow-up data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and security	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))	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: STEINMETZ LEMAITRE 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No