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The Angel® Catheter Pivotal Clinical Trial

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ClinicalTrials.gov Identifier: NCT02186223
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
CardioMed Device Consultants, LLC
Intrinsic Imaging, LLC
Novella Clinical
Information provided by (Responsible Party):
BiO2 Medical

Study Description
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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).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism Trauma Device: The Angel® Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: The Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom From Clinically Significant PE or Fatal PE During Treatment Period [ 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) ]
    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 Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. Incidence of PEs Averted [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186223


Locations
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Sponsors and Collaborators
BiO2 Medical
CardioMed Device Consultants, LLC
Intrinsic Imaging, LLC
Novella Clinical
Investigators
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Principal Investigator: Victor Tapson, MD Cedars Sinai
More Information
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Responsible Party: BiO2 Medical
ClinicalTrials.gov Identifier: NCT02186223    
Other Study ID Numbers: QD-230
First Posted: July 10, 2014    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BiO2 Medical:
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
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases