NCT02186223

The Angel® Catheter Pivotal Clinical Trial

The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: BiO2 Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis
• Venous Thromboembolism
• Trauma

Interventions

Type	Name	Description
DEVICE	The Angel® Catheter	The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-07-10
• Last updated: 2017-04-04
• Results posted: 2017-04-04

Locations

21 sites across 1 country: United States