Aneurysm Abdominal, Arterial Disease Occlusive, Peripheral Aneurysms, Prothesis
Conditions
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.
Interventions
DEVICEVascular 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.
Sponsors
Eclevar Medtech
Perouse Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary performance endpoint | 1 year | primary patency rate |
| Primary safety endpoint | 1 year | limb salvage rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| Limb salvage rate | 5 years | freedom % from target limb major amputation |
| Adverse events | 5 years | any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events |
| Mortality rate | 5 years | freedom % from death |
| Primary patency rate | 5 years | patent grafts without any procedure or intervention of the conduit itself |
Countries
France
Outcome results
None listed