NCT05517876

A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 212 (actual)
• Sponsor: Perouse Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Vascular Surgery
• Peripheral Vascular Surgery
• Vascular Prothesis
• Aneurysm Abdominal
• Aneurysm; Peripheral
• Obliterative Arterail Disease

Interventions

Type	Name	Description
DEVICE	Vascular 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).

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2022-08-26
• Last updated: 2022-08-26

Locations

1 site across 1 country: France