Angel® Catheter Early Feasibility Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01847196
Recruitment Status : Terminated (IDE approval received for larger Pivotal Study)
First Posted : May 6, 2013
Results First Posted : August 14, 2015
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
BiO2 Medical

May 2, 2013
May 6, 2013
February 18, 2015
August 14, 2015
August 26, 2015
November 2013
June 2014   (Final data collection date for primary outcome measure)
Number of Adverse Events Occuring for All Evaluable Subjects [ Time Frame: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days ]
All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.
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Complete list of historical versions of study NCT01847196 on Archive Site
Device Performance [ Time Frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days ]
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Angel® Catheter Early Feasibility Clinical Study
A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism
The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.


  1. Primary Endpoints:

    a. Initial Insights into Safety

    • Success in delivery, maintenance and removal of the Angel® Catheter.
    • Incidence and seriousness of all adverse events.
    • Incidence of device or procedure-related adverse events.
  2. Secondary Endpoints:

    • Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device.
    • Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure)
    • Evaluate operator challenges with device use (human factors).
    • Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment.


The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted.


The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Venous Thromboembolism
Device: Angel® Catheter
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). 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 device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.
Other Names:
  • Angel Catheter
  • 2011-0420
Experimental: Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
Intervention: Device: Angel® Catheter
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2014
June 2014   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA (Must Answer YES to all Inclusion Criteria):

  1. Subject or legally authorized representative is willing and able to provide written informed consent, AND
  2. Subject is 18 years or older, AND
  3. Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND
  4. Subject has a clinical need for a Central Venous Catheter, and/or the subject has an existing Central Venous Catheter that has been in place for <36 hours before Angel® Catheter placement, AND
  5. Subject is considered at high risk for PE and meets ONE of the following criteria:

    1. Subject has multiple trauma with at least ONE of the following:

      • Severe head injury
      • Head injury with a long bone fracture
      • Spinal cord injury with paraplegia or quadriplegia
      • Multiple (≥2) long bone fractures
      • Multiple (≥2) long bone fractures with pelvic fracture
      • Pelvic fracture requiring open fixation
    2. Critically ill subject in the Intensive Care Unit with at least ONE of the following:

      • Hemorrhagic or ischemic stroke
      • Multiple organ failure
      • Active or recent bleeding (within the past 2 weeks)
      • Severe sepsis
      • Lower extremity DVT
      • Anticipated ventilator requirement of greater than one week
    3. Critically ill subject requiring temporary (≥48 hours) interruption of medical thromboprophylaxis (prophylactic anticoagulation)

EXCLUSION CRITERIA (Must Answer NO to All Exclusion Criteria):

  1. Subject is pregnant or lactating
  2. BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at
  3. Subject has a pre-existing IVC filter in place
  4. Subject is currently receiving prophylactic anticoagulation, other than aspirin or Plavix. Specifically, the subject is receiving any of the following medications: heparin, low molecular weight heparin, factor Xa inhibitors (i.e. xabans), Coumadin, and thrombin inhibitors.
  5. Subject has a diagnosis of pulmonary embolism
  6. Subject is participating in another clinical investigation
  7. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
  8. Subject has functioning pelvic renal allograft on the only side available for device insertion
  9. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
  10. Anatomic inability to place the Angel® Catheter (including a history of thrombosis of venous system on side of proposed access)
  11. Anticipated survival ≤48 hours
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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BiO2 Medical
BiO2 Medical
Not Provided
Principal Investigator: Martin Schreiber, MD Oregon Health and Science University
Principal Investigator: Larry Martin, MD University of Mississippi Medical Center
Principal Investigator: John Holcomb, MD The University of Texas Health Science Center, Houston
Principal Investigator: Michael Cripps, MD University of Texas Southwestern Medical Center (Dallas)
BiO2 Medical
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP