Safety and Performance of POLYTHESE® Vascular Prosthesis

Perouse Medical

Status: Completed

Conditions: Marfan Syndrome; Aneurysm Arterial; Ehlers-Danlos Syndrome; Arterial Dissections; Peripheral Arterial Disease

Treatments: Procedure: Implantation with POLYTHESE®

Study type: Observational

Funder types: Industry

Identifiers

NCT05516043

2021-PT-01

Details and patient eligibility

About

POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.

PMCF Study.

Enrollment: 256 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must meet 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

• none

Trial design