Safety and Performance of POLYTHESE® Vascular Prosthesis

NCT ID: NCT05516043

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-11-26

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Implantation with POLYTHESE®

thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria

\- none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eclevar Medtech

INDUSTRY

Sponsor Role collaborator

Perouse Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU CAEN

Caen, , France

Site Status

CHU de NANTES

Nantes, , France

Site Status

CHU La Pitié Salpétrière

Paris, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2021-PT-01

Identifier Type: -

Identifier Source: org_study_id

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