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The Angel® Catheter Pivotal Clinical Trial

Primary Purpose

Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Angel® Catheter
Sponsored by
BiO2 Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cedars-Sinai Medical Center
  • UC San Diego Medical Center
  • Medical Center of the Rockies
  • Delray Medical Center
  • Broward Health Medical Center
  • UF Health Shands Cancer Hospital
  • Jackson Memorial Hospital
  • St. Mary's Medical Center
  • University of Maryland Medical Center
  • Mercy Hospital St. Louis
  • Cooper University Hospital
  • University of New Mexico Health
  • Mount Sinai Hospital
  • Wake Forest Baptist Health
  • St. Luke's University Health Network
  • Medical University of South Carolina
  • Regional One Health
  • Vanderbilt University Medical Center
  • John Peter Smith Health Network
  • Ben Taub Hospital
  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Angel® Catheter

Arm Description

All eligible subjects will receive an Angel® Catheter.

Outcomes

Primary Outcome Measures

Freedom From Clinically Significant PE or Fatal PE During Treatment Period
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 Outcome Measures

Incidence of Acute Proximal Deep Vein Thrombosis
Incidence of Catheter Related Thrombosis
Incidence of Catheter Related Blood Stream Infections
Incidence of Major Bleeding Event
Incidence of PEs Averted
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.

Full Information

First Posted
July 7, 2014
Last Updated
February 17, 2017
Sponsor
BiO2 Medical
Collaborators
CardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT02186223
Brief Title
The Angel® Catheter Pivotal Clinical Trial
Official Title
The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BiO2 Medical
Collaborators
CardioMed Device Consultants, LLC, Intrinsic Imaging, LLC, Novella Clinical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism, Trauma
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Angel® Catheter
Arm Type
Experimental
Arm Description
All eligible subjects will receive an Angel® Catheter.
Intervention Type
Device
Intervention Name(s)
The Angel® Catheter
Intervention Description
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 Outcome Measure Information:
Title
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
Description
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.
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
Incidence of PEs Averted
Description
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.
Time Frame
During the pre-removal cavogram (An average of 6.8 days after device insertion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Tapson, MD
Organizational Affiliation
Cedars Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UC San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33483
Country
United States
Facility Name
Broward Health Medical Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Hospital St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
University of New Mexico Health
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Regional One Health
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
John Peter Smith Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Angel® Catheter Pivotal Clinical Trial

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