The Angel® Catheter Pivotal Clinical Trial

February 17, 2017 updated by: BiO2 Medical

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Florida
      • Delray Beach, Florida, United States, 33483
        • Delray Medical Center
      • Ft. Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Gainesville, Florida, United States, 32608
        • UF Health Shands Cancer Hospital
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Health
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional One Health
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • John Peter Smith Health Network
      • Houston, Texas, United States, 77030
        • Ben Taub Hospital
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BiO2 Medical

Collaborators

Novella Clinical
CardioMed Device Consultants, LLC
Intrinsic Imaging, LLC

Investigators

  • Principal Investigator: Victor Tapson, MD, Cedars Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QD-230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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