Angel® Catheter Early Feasibility Clinical Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
BiO2 Medical
ClinicalTrials.gov Identifier:
NCT01847196
First received: May 2, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Device: Angel® Catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by BiO2 Medical:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 6
Study Start Date: November 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
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

Detailed Description:

STUDY ENDPOINTS

  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.

ENROLLMENT AND SUBJECT SAMPLE SIZE

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.

STUDY DURATION

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 http://nhlbisupport.com/bmi/bminojs.htm
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847196

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9158
University of Texas Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
BiO2 Medical
Investigators
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)
  More Information

No publications provided

Responsible Party: BiO2 Medical
ClinicalTrials.gov Identifier: NCT01847196     History of Changes
Other Study ID Numbers: QD-155
Study First Received: May 2, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

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:
Critical Illness
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014