Angel® Catheter Early Feasibility Clinical Study
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.
Deep Vein Thrombosis
Device: Angel® Catheter
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism|
- 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 ] [ Designated as safety issue: Yes ]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.
- Device Performance [ Time Frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
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.
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.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847196
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390-9158|
|University of Texas Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Martin Schreiber, MD||Oregon Health and Science University|
|Principal Investigator:||Larry Martin, MD||University of Mississippi Medical Center|
|Principal Investigator:||John Holcomb, MD||The University of Texas Health Science Center, Houston|
|Principal Investigator:||Michael Cripps, MD||University of Texas Southwestern Medical Center (Dallas)|