NCT05519826

A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 373 (actual)
• Sponsor: Perouse Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aneurysm Abdominal
• Peripheral Aneurysms
• Arterial Disease Occlusive
• Prothesis

Interventions

Type	Name	Description
DEVICE	Vascular surgery	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2022-08-29
• Last updated: 2022-08-29

Locations

1 site across 1 country: France