Deep Vein Thrombosis, Pulmonary Embolism, Trauma, 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 multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
Interventions
DEVICEThe Angel® Catheter
The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into 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 (less than 30 days) vascular access via the femoral vein.
Sponsors
CardioMed Device Consultants, LLC
Intrinsic Imaging, LLC
Novella Clinical
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 or legally authorized representative is willing and able to provide written informed consent, 2. Subject is 18 years or older, 3. Subject is expected to remain in a critical care setting for at least 72 hours, AND at least one of the following inclusion criteria (4,5, and/or 6) 4. Subject has recognized contraindications to standard pharmacological thromboprophylaxis including: * Active bleeding or at high risk for bleeding OR * Hypersensitivity to pharmacological thromboprophylaxis OR * History of severe heparin induced thrombocytopenia OR * Severe thrombocytopenia 5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation 6. Subject requires a temporary interruption (\>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
Exclusion criteria
1. Subject is pregnant 2. Subject is in treatment with an investigational drug or device within 30 days prior to enrollment 3. Subject has a pre-existing IVC filter in place 4. BMI = \> 45 5. Subject has functioning pelvic renal allograft on the only side available for device insertion 6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted 7. Anatomic inability to place the Angel® Catheter 8. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Clinically Significant PE or Fatal PE During Treatment Period | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days) | 1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Proximal Deep Vein Thrombosis | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) | — |
| Incidence of Catheter Related Thrombosis | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) | — |
| Incidence of Catheter Related Blood Stream Infections | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) | — |
| Incidence of Major Bleeding Event | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) | — |
| Incidence of PEs Averted | During the pre-removal cavogram (An average of 6.8 days after device insertion) | During the pre-removal cavogram, the presence of significant clot (\>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Angel® Catheter All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into 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 (less than 30 days) vascular access via the femoral vein. | 163 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Device in place less than 48 hours | 9 |
| Overall Study | Not eligible for device placement | 6 |
| Overall Study | Unable to obtain femoral access | 3 |
Baseline characteristics
| Characteristic | The Angel® Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants |
| Age, Continuous | 44.07 years STANDARD_DEVIATION 18.66 |
| Age, Customized | 43 years |
| Bleeding Risk Active bleeding | 67 Participants |
| Bleeding Risk At high risk for bleeding | 69 Participants |
| Bleeding Risk History of bleeding | 13 Participants |
| Contraindications to anticoagulation Active or high risk for bleeding | 153 Participants |
| Contraindications to anticoagulation History of severe heparin induced thrombocytopenia | 0 Participants |
| Contraindications to anticoagulation Hypersensitivity to anticoagulation | 0 Participants |
| Contraindications to anticoagulation Other | 11 Participants |
| Contraindications to anticoagulation Severe thrombocytopenia | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Indications for the Angel® Catheter Placement Acute LE DVT or PE & contraindicated to anticoagul | 8 Participants |
| Indications for the Angel® Catheter Placement Prophylactic Use of Indications for the Angel® Cat | 160 Participants |
| Indications for the Angel® Catheter Placement Recognized contraindications to anticoagulation | 160 Participants |
| Indications for the Angel® Catheter Placement Temporary interruption of anticoagulation | 10 Participants |
| Injury Classification Critical (25+) | 92 Participants |
| Injury Classification Minimal (1-9) | 7 Participants |
| Injury Classification Moderate (10-15) | 11 Participants |
| Injury Classification Severe (16-24) | 41 Participants |
| Injury Severity Score (for trauma subjects) | 27.68 Injury Severity Score STANDARD_DEVIATION 11.94 |
| Medical History & Concomitant Conditions Blood and lymphatic system disorders | 53 Participants |
| Medical History & Concomitant Conditions Cardiac disorders | 43 Participants |
| Medical History & Concomitant Conditions Ear and labyrinth disorders | 2 Participants |
| Medical History & Concomitant Conditions Endocrine disorders | 7 Participants |
| Medical History & Concomitant Conditions Eye disorders | 2 Participants |
| Medical History & Concomitant Conditions Gastrointestinal disorders | 38 Participants |
| Medical History & Concomitant Conditions General disorders and administration site conditio | 37 Participants |
| Medical History & Concomitant Conditions Hepatobiliary disorders | 8 Participants |
| Medical History & Concomitant Conditions Immune system disorders | 2 Participants |
| Medical History & Concomitant Conditions Infections and infestations | 28 Participants |
| Medical History & Concomitant Conditions Injury, poisoning, and procedural complications | 149 Participants |
| Medical History & Concomitant Conditions Investigations | 43 Participants |
| Medical History & Concomitant Conditions Metabolism and nutrition disorders | 58 Participants |
| Medical History & Concomitant Conditions Musculoskeletal and connective tissue disorders | 26 Participants |
| Medical History & Concomitant Conditions Neoplasms benign, malignant, and unspecified | 12 Participants |
| Medical History & Concomitant Conditions Nervous system disorders | 111 Participants |
| Medical History & Concomitant Conditions Psychiatric disorders | 24 Participants |
| Medical History & Concomitant Conditions Renal and urinary disorders | 19 Participants |
| Medical History & Concomitant Conditions Reproductive system and breast disorders | 11 Participants |
| Medical History & Concomitant Conditions Respiratory, thoracic and mediastinal disorders | 101 Participants |
| Medical History & Concomitant Conditions Skin and subcutaneous tissue disorders | 5 Participants |
| Medical History & Concomitant Conditions Social circumstances | 3 Participants |
| Medical History & Concomitant Conditions Surgical and medical procedures | 78 Participants |
| Medical History & Concomitant Conditions Vascular disorders | 73 Participants |
| Need for vasopressors before Angel® Catheter insertion | 40 Participants |
| Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion Long term CVC | 8 Participants |
| Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion None | 46 Participants |
| Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion Short term CVC | 109 Participants |
| Primary ICU Admission Diagnosis Medical | 6 Participants |
| Primary ICU Admission Diagnosis Neurological | 4 Participants |
| Primary ICU Admission Diagnosis Surgical | 2 Participants |
| Primary ICU Admission Diagnosis Trauma | 151 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Region of Enrollment United States | 163 participants |
| Severity of Active Bleeding Major bleeding | 56 Participants |
| Severity of Active Bleeding Minor bleeding | 11 Participants |
| Sex: Female, Male Female | 122 Participants |
| Sex: Female, Male Male | 41 Participants |
| Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History Deep Vein Thrombosis (DVT) | 16 Participants |
| Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History PE and DVT | 1 Participants |
| Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History Pulmonary Embolism (PE) | 3 Participants |
| Supplemental Oxygen at Enrollment | 150 Participants |
| Time from admission to the hospital to admission to ICU | 7.49 hours STANDARD_DEVIATION 27.34 |
| Type of supplemental oxygen CPAP-BiPAP | 0 Participants |
| Type of supplemental oxygen Mechanical ventilation | 127 Participants |
| Type of supplemental oxygen Nasal cannula/face mask | 20 Participants |
| Type of supplemental oxygen Other | 2 Participants |
| Type of trauma (for trauma subjects) Abdomen | 41 Participants |
| Type of trauma (for trauma subjects) Chest | 63 Participants |
| Type of trauma (for trauma subjects) Head Bleed (Subcategory of Head/Spinal Trauma) | 102 Participants |
| Type of trauma (for trauma subjects) Head/Spinal Trauma | 129 Participants |
| Type of trauma (for trauma subjects) Lower Extremity Trauma | 54 Participants |
| Type of trauma (for trauma subjects) More than one area affected | 80 Participants |
| Use of mechanical DVT preventive devices At least 1 type of preventive device used | 145 Participants |
| Use of mechanical DVT preventive devices Compressive stockings | 10 Participants |
| Use of mechanical DVT preventive devices Other | 27 Participants |
| Use of mechanical DVT preventive devices Pneumatic compression | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 114 / 163 |
| serious Total, serious adverse events | 49 / 163 |
Outcome results
Primary
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Freedom From Clinically Significant PE or Fatal PE During Treatment Period | 163 Participants |
Secondary
Incidence of Acute Proximal Deep Vein Thrombosis
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Incidence of Acute Proximal Deep Vein Thrombosis | 30 Participants |
Secondary
Incidence of Catheter Related Blood Stream Infections
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Incidence of Catheter Related Blood Stream Infections | 0 Participants |
Secondary
Incidence of Catheter Related Thrombosis
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Incidence of Catheter Related Thrombosis | 20 Participants |
Secondary
Incidence of Major Bleeding Event
Time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Incidence of Major Bleeding Event | 5 Participants |
Secondary
Incidence of PEs Averted
During the pre-removal cavogram, the presence of significant clot (\>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.
Time frame: During the pre-removal cavogram (An average of 6.8 days after device insertion)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Angel® Catheter | Incidence of PEs Averted | 14 Participants |