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.

NCT05055102 | Completed

• 1 other identifier: STEINMETZ LEMAITRE 2020
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Major surgical reintervention

  5 years

• Primary permeability

  5 years

• Secondary permeability

  5 years

• Dilatation of the prothesis

  5 years

• Occurence of MAVE and MACE

  5 years

Study Arms (1)

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

Interventions

Data collection OTHER

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

Patient with WOVEX bifurcated prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: January 16, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

FR (1)