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NCT05519826 | COMPLETED | Aneurysm Abdominal


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

Perouse Medical

Brief 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.

Condition or disease

Aneurysm Abdominal

Peripheral Aneurysms

Arterial Disease Occlusive

Intention

Intervention/treatment

Vascular surgery

Study Type : OBSERVATIONAL
Estimated Enrollment : 373 participants
Official Title : A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
Actual Study Start Date : 2022-03-01
Estimated Primary Completion Date : 2022-04-20
Estimated Study Completion Date : 2022-04-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study
    • Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
    Exclusion Criteria
    • * Patients who refused the collection of their personal data.

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

Location Details

NCT05519826


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

France,

Nantes of Chu

Nantes, France, 44093

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