Safety and Performance of POLYTHESE® Vascular Prosthesis

August 23, 2022 updated by: Perouse Medical

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • CHU Caen
      • Nantes, France, 44000
        • CHU de Nantes
      • PAris, France, 75014
        • Chu La Pitie Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance: Primary patency rate
Time Frame: 1 year
Patency rate
1 year
Safety : Mortality rate
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
Mortality rate
Time Frame: 5 years
freedom % from death
5 years
Adverse events
Time Frame: 5 years
any documented adverse events, including anticipated and non-anticipated adverse events
5 years
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.
5 years
Primary patency rate
Time Frame: 5 years
rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)
5 years
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
5 years
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 years
Limb salvage rate
Time Frame: 5 years
defined as freedom % from target limb amputation
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perouse Medical

Collaborators

Eclevar Medtech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

October 21, 2021

Study Completion (Actual)

November 26, 2021

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-PT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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