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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis

Intervention / Treatment
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* Device: Vascular surgery


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vascular surgery|POLYMAILLE® EXTRA THIN 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. Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal). Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary performance endpoint | primary patency rate | 1 year | 
| Primary safety endpoint | limb salvage rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | 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 | patent grafts without any procedure or intervention of the conduit itself | 5 years | 
| Primary assisted patency rate | 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) | 5 years | 
| -Secondary patency rate | 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 | 5 years | 
| Device Failure | 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 | freedom % from death | 5 years | 
| Limb salvage rate | freedom % from target limb major amputation | 5 years | 
| Adverse events | any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events | 5 years |