Abdominal Vascular Surgery, Aneurysm Abdominal, Aneurysm; Peripheral, Obliterative Arterail Disease, Peripheral Vascular Surgery, Vascular Prothesis
Conditions
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.
Interventions
DEVICEVascular abdominal or peripheral surgery
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 abdominal aorto-aortic and/or 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).
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 have objected to the collect of their data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary performance endpoint | 1 year | primary patency rate |
| Primary safety endpoint | 30 days | mortality rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate | 5 years | rate of patent grafts without any procedure or intervention of the conduit itself |
| 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 and non-anticipated adverse events |
| Mortality rate | 5 years | freedom % from death |
| Limb salvage rate | 5 years | freedom % from target limb amputation |
| 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. |
Countries
France
Outcome results
None listed