NCT05519826
Completed
Not Applicable
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm Abdominal
- Sponsor
- Perouse Medical
- Enrollment
- 373
- Locations
- 1
- Primary Endpoint
- Primary safety endpoint
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Primary safety endpoint
Time Frame: 1 year
limb salvage rate
Primary performance endpoint
Time Frame: 1 year
primary patency rate
Secondary Outcomes
- Procedural success rate(5 years)
- Primary assisted patency rate(5 years)
- -Secondary patency rate(5 years)
- Adverse events(5 years)
- Primary patency rate(5 years)
- Device Failure(5 years)
- Limb salvage rate(5 years)
- Mortality rate(5 years)
Study Sites (1)
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