NCT01403090

Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism

A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: BiO2 Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 .

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DEVICE	Angel Catheter	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-07-27
• Last updated: 2013-05-20
• Results posted: 2013-05-20

Locations

2 sites across 1 country: Colombia