The Angel® Catheter Pivotal Clinical Trial

Study Overview
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Brief Summary
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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).

Official Title
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The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects

Conditions
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Trauma, Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism

Intervention / Treatment
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* Device: The Angel® Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or legally authorized representative is willing and able to provide written informed consent, Subject is 18 years or older, 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) 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 Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure Exclusion Criteria: Subject is pregnant Subject is in treatment with an investigational drug or device within 30 days prior to enrollment Subject has a pre-existing IVC filter in place BMI = > 45 Subject has functioning pelvic renal allograft on the only side available for device insertion Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted Anatomic inability to place the Angel® Catheter Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Angel® Catheter<br>All eligible subjects will receive an Angel® Catheter. | Device: The Angel® Catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Clinically Significant PE or Fatal PE During Treatment Period | 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. 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 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. | During the pre-removal cavogram (An average of 6.8 days after device insertion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VTE, Pulmonary Embolism, PE, DVT, Deep Vein Thrombosis, Venous Thromboembolism, prophylaxis, thromboprophylaxis, contraindications to thromboprophylaxis, prophylactic, prevention, Inferior vena cava filter, IVC filter, filter, prevention of pulmonary embolism, trauma, critically-ill