Safety and Performance of POLYTHESE® Vascular Prosthesis

A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05516043

Enrollment

256

Registered

2022-08-25

Start date

2021-07-07

Completion date

2021-11-26

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

PROCEDUREImplantation with POLYTHESE®

thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Performance: Primary patency rate	1 year	Patency rate
Safety : Mortality rate	30 days	—

Secondary

Measure	Time frame	Description
Primary patency rate	5 years	rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)
Primary assisted patency rate	5 years	defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation
Device Failure	5 years	* 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
Secondary patency	5 years	defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation
Limb salvage rate	5 years	defined as freedom % from target limb amputation
Adverse events	5 years	any documented adverse events, including anticipated and non-anticipated adverse events
Mortality rate	5 years	freedom % from death
Procedural success rate	5 years	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026