The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Enrollment
12
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
Time frame: 30 days
Primary Performance Endpoint
Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site
Time frame: 30 days
Secondary Safety Endpoint
Safety: Incidence of all adverse events at 30 days
Time frame: 30 days
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