A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

Completed

• Conditions: Aneurysm Abdominal; Arterial Disease Occlusive; Prothesis; Peripheral Aneurysms

• Registration Number: NCT05519826
• Lead Sponsor: Perouse Medical

Brief Summary

The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-26
• Study First Posted: 2022-08-29
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Patients must meet all 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

• Patients who refused the collection of their personal data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint	1 year	limb salvage rate
Primary performance endpoint	1 year	primary patency rate

Secondary Outcome Measures

Name	Time	Method
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 assisted patency rate	5 years	rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, however with graft never thrombosed (graft occlusion)
-Secondary patency rate	5 years	rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, lysis and/or thrombectomy
Adverse events	5 years	any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events
Primary patency rate	5 years	patent grafts without any procedure or intervention of the conduit itself
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
Limb salvage rate	5 years	freedom % from target limb major amputation
Mortality rate	5 years	freedom % from death

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France