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NCT Number: NCT02186223

The Angel® Catheter Pivotal Clinical Trial

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).

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Critical Illness Deep Vein Thrombosis Disease Attributes Embolism Embolism and Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Thromboembolism Thrombosis Trauma Vascular Diseases Venous Thromboembolism Venous Thrombosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The Angel® Catheter

Device

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.

Primary outcomes

  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)

    • 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.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

BiO2 Medical

Industry

Collaborators

  • CardioMed Device Consultants, LLC
  • Intrinsic Imaging, LLC
  • Novella Clinical

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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