The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
8
The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
Clinica las Americas
Medellín, Antioquia, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Safety
Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
Time frame: 30 days
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