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.
Study Type
OBSERVATIONAL
Enrollment
373
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.
CHU de Nantes
Nantes, France
Primary performance endpoint
primary patency rate
Time frame: 1 year
Primary safety endpoint
limb salvage rate
Time frame: 1 year
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.
Time frame: 5 years
Primary patency rate
patent grafts without any procedure or intervention of the conduit itself
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 5 years
Mortality rate
freedom % from death
Time frame: 5 years
Limb salvage rate
freedom % from target limb major amputation
Time frame: 5 years
Adverse events
any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events
Time frame: 5 years
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