Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Central Line Catheter, Vena Cava Filters
Brief summary
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. 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 primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
Interventions
DEVICEAngel Catheter
The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
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
1. Subject is 18 years and older 2. Be admitted to the hospital One of the following two criteria: 3. Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria: * Contraindications for anticoagulation * Recurrent PE despite adequate anticoagulation * Emergency treatment following massive pulmonary embolism 4. Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including: * Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation * severe head injury with coma * severe hemorrhagic stroke with coma * head injury with a long bone fracture * spinal cord injury with paraplegia or quadriplegia * multiple (≥2) long bone fractures with pelvic fracture * multiple (≥4) long bone fractures * Critically ill patients in the Medical or Surgical Intensive Care Unit with high risk of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter * Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central
Exclusion criteria
1. Patient is less than 18 years 2. Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit 3. Patient or next legal representative cannot give informed consent 4. Patients with anticipated survival \< 2 days (catastrophic illness) 5. Body mass index greater than 35 6. Patient has a pre-existing filter 7. Participation in another simultaneous interventional medical investigation or interventional trial. 8. Patient has indications for a permanent filter at the time of the initial evaluation 9. Patient has an uncontrollable coagulopathy with active bleeding. 10. Patient with proven endocarditis or bacteremia 11. Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol 12. Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins 13. Patient with functioning pelvic renal allograft on the only side available for device insertion 14. Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 30 days | Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects. |
Countries
Colombia
Participant flow
Recruitment details
Recruitment started at the Hospital Pablo Tobon Uribe and was then followed at the clinical las Americas. Eight patients were recruited in the initial phase of the study
Participants by arm
| Arm | Count |
|---|---|
| Angel Catheter Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Angel Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 35.4 years STANDARD_DEVIATION 16.2 |
| Region of Enrollment Colombia | 8 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 2 / 8 |
Outcome results
Primary
Safety
Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angel Catheter | Safety | 0 participants |