A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

Perouse Medical

Status: Completed

Conditions: Vascular Prothesis; Obliterative Arterail Disease; Aneurysm Abdominal; Aneurysm; Peripheral; Abdominal Vascular Surgery; Peripheral Vascular Surgery

Treatments: Device: Vascular abdominal or peripheral surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05517876

2020-PMC-01

Details and patient eligibility

About

Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).

Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.

Enrollment: 212 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 have objected to the collect of their data.

Trial design