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| Name | Class |
|---|---|
| Eclevar Medtech | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular surgery | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary performance endpoint | primary patency rate | 1 year |
| Primary safety endpoint | limb salvage rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate |
| 5 years |
| Primary patency rate |
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Inclusion Criteria:
Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
Exclusion Criteria:
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Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include:
Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as:
Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
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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 |
| 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 |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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