NCT01847196

Angel® Catheter Early Feasibility Clinical Study

A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: BiO2 Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.

Detailed description

STUDY ENDPOINTS 1. Primary Endpoints: a. Initial Insights into Safety * Success in delivery, maintenance and removal of the Angel® Catheter. * Incidence and seriousness of all adverse events. * Incidence of device or procedure-related adverse events. 2. Secondary Endpoints: * Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device. * Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure) * Evaluate operator challenges with device use (human factors). * Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment. ENROLLMENT AND SUBJECT SAMPLE SIZE The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted. STUDY DURATION The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DEVICE	Angel® Catheter	The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). 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 device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-05-06
• Last updated: 2015-08-26
• Results posted: 2015-08-14

Locations

4 sites across 1 country: United States