Safety and Performance of POLYTHESE® Vascular Prosthesis

Perouse Medical256 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

256

Conditions

Aneurysm Arterial Peripheral Arterial Disease Marfan Syndrome Arterial Dissections Ehlers-Danlos Syndrome

Interventions

Implantation with POLYTHESE®PROCEDURE

thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (3)

CHU CAEN

Caen, France

CHU de NANTES

Nantes, France

CHU La Pitié Salpétrière

Paris, France

Outcomes

Primary Outcomes

Performance: Primary patency rate

Patency rate

Time frame: 1 year

Safety : Mortality rate

Time frame: 30 days

Secondary Outcomes

Procedural success rate

Ability to use with no need for replacement by another device and, Effective vascular flow restoration after procedure and, In case of aneurysm, exclusion of aneurysmal portion after procedure.

Time frame: 5 years

Primary patency rate

rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)

Time frame: 5 years

Primary assisted patency rate

defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation

Time frame: 5 years

Secondary patency

defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation

Time frame: 5 years

Device Failure

* Uncontrolled blood leakage from device * Loss of structural integrity, e.g. rupture and/or exaggerated dilation (\> 50 %) * Occlusion of the device * Total or partial replacement of the device required

Time frame: 5 years

Mortality rate

freedom % from death

Data from ClinicalTrials.gov

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