Skip to main content
OpenTrials
Completed

NCT Number: NCT05516043

Safety and Performance of POLYTHESE® Vascular Prosthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aneurysm Arterial Abnormalities, Multiple Aneurysm Arterial Dissections Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dissection, Blood Vessel Ehlers-Danlos Syndrome Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Marfan Syndrome Musculoskeletal Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU CAEN, Caen, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation with POLYTHESE®

Procedure

thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Primary outcomes

  1. Performance: Primary patency rate

    Time frame: 1 year

    Patency rate

  2. Safety : Mortality rate

    Time frame: 30 days

Secondary outcomes

  1. Procedural success rate

    Time frame: 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.

  2. Primary patency rate

    Time frame: 5 years

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

  3. Primary assisted patency rate

    Time frame: 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

  4. Secondary patency

    Time frame: 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

  5. Device Failure

    Time frame: 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

  6. Mortality rate

    Time frame: 5 years

    freedom % from death

  7. Limb salvage rate

    Time frame: 5 years

    defined as freedom % from target limb amputation

  8. Adverse events

    Time frame: 5 years

    any documented adverse events, including anticipated and non-anticipated adverse events

Sponsors and collaborators

Lead sponsor

Perouse Medical

Industry

Collaborators

  • Eclevar Medtech

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.