A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

Perouse Medical

Status: Completed

Conditions: Peripheral Aneurysms; Aneurysm Abdominal; Arterial Disease Occlusive; Prothesis

Treatments: Device: Vascular surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05519826

PMET-2022-01

Details and patient eligibility

About

The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.

Enrollment: 373 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study:

Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion criteria

• Patients who refused the collection of their personal data.