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| Name | Class |
|---|---|
| Eclevar Medtech | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular abdominal or peripheral surgery | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary performance endpoint | primary patency rate | 1 year |
| Primary safety endpoint | mortality rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate |
| 5 years |
| Primary patency rate |
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Inclusion Criteria:
Exclusion Criteria:
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All potential subjects and will select those who are appropriate for study inclusion, i.e. subjects implanted with POLYMAILLE® C for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYMAILLE® C implanted for at least one year and up to 5 years will be included in the study.
All data will be retrieved from medical charts for each patient from time of surgery (considered as index date) until a maximum of 5 years after surgery.
A minimum of 100 subjects will be evaluated for each main location of surgery (peripheral and abdominal).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes' | Nantes | 44093 | France |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2021 | Aug 24, 2022 |
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rate of 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 amputation | 5 years |
| Adverse events | any documented adverse events, including anticipated and non-anticipated adverse events | 5 years |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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