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

NCT05517876 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 212

Last updated 2022-08-26

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Eclevar Medtech

    collaborator INDUSTRY

  • Perouse Medical

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517876 on ClinicalTrials.gov