Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, PE, DVT, Deep Vein Thrombosis, VTE, Venous Thromboembolism, prophylaxis, thromboprophylaxis, contraindications to thromboprophylaxis, prophylactic, prevention, Inferior vena cava filter, IVC filter, filter, prevention of pulmonary embolism, trauma, critically-ill
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.
Interventions
DEVICEAngel® 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.
Sponsors
BiO2 Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Must Answer YES to all Inclusion Criteria): 1. Subject or legally authorized representative is willing and able to provide written informed consent, AND 2. Subject is 18 years or older, AND 3. Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND 4. Subject has a clinical need for a Central Venous Catheter, and/or the subject has an existing Central Venous Catheter that has been in place for \<36 hours before Angel® Catheter placement, AND 5. Subject is considered at high risk for PE and meets ONE of the following criteria: 1. Subject has multiple trauma with at least ONE of the following: * Severe head injury * Head injury with a long bone fracture * Spinal cord injury with paraplegia or quadriplegia * Multiple (≥2) long bone fractures * Multiple (≥2) long bone fractures with pelvic fracture * Pelvic fracture requiring open fixation 2. Critically ill subject in the Intensive Care Unit with at least ONE of the following: * Hemorrhagic or ischemic stroke * Multiple organ failure * Active or recent bleeding (within the past 2 weeks) * Severe sepsis * Lower extremity DVT * Anticipated ventilator requirement of greater than one week 3. Critically ill subject requiring temporary (≥48 hours) interruption of medical thromboprophylaxis (prophylactic anticoagulation)
Exclusion criteria
(Must Answer NO to All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Occuring for All Evaluable Subjects | 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
| Measure | Time frame |
|---|---|
| Device Performance | From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days |
Countries
United States
Participant flow
Pre-assignment details
For this study, enrollment was defined as the time of consent. There was a possibility that a consented subject could still become ineligible prior to Angel® Catheter placement. One (1) of the six (6) enrolled (i.e. consented) subjects became ineligible prior to Angel® Catheter placement, and did not go on to start the study.
Participants by arm
| Arm | Count |
|---|---|
| Angel® Catheter All eligible subjects received an 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Angel® Catheter |
|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 10.4 |
| Baseline Central Venous Catheter in Place No | 3 participants |
| Baseline Central Venous Catheter in Place Yes | 2 participants |
| Baseline Venous Thromboembolism No | 5 participants |
| Baseline Venous Thromboembolism Yes | 0 participants |
| Body Mass Index | 25.8 kg/m^2 STANDARD_DEVIATION 4.5 |
| Hepatic Trauma at Baseline No | 2 participants |
| Hepatic Trauma at Baseline Yes | 3 participants |
| Multiple Fractures of Upper and Lower Limbs at Baseline No | 4 participants |
| Multiple Fractures of Upper and Lower Limbs at Baseline Yes | 1 participants |
| Musculoskeletal Fractures at Baseline No | 1 participants |
| Musculoskeletal Fractures at Baseline Yes | 4 participants |
| Respiratory Trauma or Distress at Baseline No | 1 participants |
| Respiratory Trauma or Distress at Baseline Yes | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
| Spinal Injury at Baseline No | 4 participants |
| Spinal Injury at Baseline Yes | 1 participants |
| Spleen/Kidney Laceration at Baseline No | 3 participants |
| Spleen/Kidney Laceration at Baseline Yes | 2 participants |
| Subarachnoid and/or Subdural Bleeding at Baseline No | 3 participants |
| Subarachnoid and/or Subdural Bleeding at Baseline Yes | 2 participants |
| Subject on Dialysis at Baseline No | 5 participants |
| Subject on Dialysis at Baseline Yes | 0 participants |
| Subject on Mechanical Ventilation at Baseline No | 3 participants |
| Subject on Mechanical Ventilation at Baseline Yes | 2 participants |
| Subject on Vasopressors at Baseline No | 5 participants |
| Subject on Vasopressors at Baseline Yes | 0 participants |
| Trauma as Primary Reason for Hospital Admission | 5 participants |
| Traumatic Brain Injury at Baseline No | 2 participants |
| Traumatic Brain Injury at Baseline Yes | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
Primary
Number of Adverse Events Occuring for All Evaluable Subjects
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.
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Thrombosis | 0 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Pulmonary Embolism | 0 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Blood Stream Infection | 0 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Deep Vein Thrombosis (DVT) | 2 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Major Bleeding | 0 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Catheter Movement >2cm | 2 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Vena Cava Perforation | 0 participants |
| Angel® Catheter | Number of Adverse Events Occuring for All Evaluable Subjects | Angel Catheter Related Death | 0 participants |
Secondary
Device Performance
Time frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angel® Catheter | Device Performance | Device Malfunctions resulting in clinical harm | 0 device malfunctions |
| Angel® Catheter | Device Performance | Total Number of Device Malfunctions | 2 device malfunctions |