Angel® Catheter Early Feasibility Clinical Study

Pulmonary Embolism Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

• NCT number: NCT01847196
• Study type: Interventional
• Source: BiO2 Medical
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Completion date: June 2014