A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

Completed

• Conditions: Vascular Prothesis; Peripheral Vascular Surgery; Obliterative Arterail Disease; Aneurysm; Peripheral; Abdominal Vascular Surgery; Aneurysm Abdominal

• Registration Number: NCT05517876
• Lead Sponsor: Perouse Medical

Brief Summary

Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).

Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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 have objected to the collect of their data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary performance endpoint	1 year	primary patency rate
Primary safety endpoint	30 days	mortality 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.
Mortality rate	5 years	freedom % from death
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)
Primary patency rate	5 years	rate of patent grafts without any procedure or intervention of the conduit itself
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.
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 amputation
Adverse events	5 years	any documented adverse events, including anticipated and non-anticipated adverse events

Trial Locations

Locations (1)

CHU de Nantes'; 🇫🇷 Nantes, France