Safety and Performance of POLYTHESE® Vascular Prosthesis

Completed

• Conditions: Ehlers-Danlos Syndrome; Marfan Syndrome; Arterial Dissections; Aneurysm Arterial; Peripheral Arterial Disease

• Registration Number: NCT05516043
• Lead Sponsor: Perouse Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Primary Completion: 2021-10-21
• Study Completion: 2021-11-26
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance: Primary patency rate	1 year	Patency rate
Safety : Mortality rate	30 days

Secondary Outcome Measures

Name	Time	Method
Mortality rate	5 years	freedom % from death
Adverse events	5 years	any documented adverse events, including anticipated and non-anticipated adverse events
Limb salvage rate	5 years	defined as freedom % from target limb amputation
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
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.
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

Trial Locations

Locations (3)

CHU La Pitié Salpétrière; 🇫🇷 PAris, France

CHU CAEN; 🇫🇷 Caen, France

CHU de NANTES; 🇫🇷 Nantes, France