A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Embolism
- Sponsor
- BiO2 Medical
- Enrollment
- 6
- Locations
- 4
- Primary Endpoint
- Number of Adverse Events Occuring for All Evaluable Subjects
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Adverse Events Occuring for All Evaluable Subjects
Time Frame: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days
All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.
Secondary Outcomes
- Device Performance(From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days)