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Angel® Catheter Early Feasibility Clinical Study

Primary Purpose

Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Angel® Catheter

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 (Must Answer YES to all Inclusion Criteria):

Subject or legally authorized representative is willing and able to provide written informed consent, AND
Subject is 18 years or older, AND
Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND
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
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):

Subject is pregnant or lactating
BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at http://nhlbisupport.com/bmi/bminojs.htm
Subject has a pre-existing IVC filter in place
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.
Subject has a diagnosis of pulmonary embolism
Subject is participating in another clinical investigation
Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
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 (including a history of thrombosis of venous system on side of proposed access)
Anticipated survival ≤48 hours

Sites / Locations

University of Mississippi Medical Center
Oregon Health and Science University
University of Texas Southwestern Medical Center - Dallas
University of Texas Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Angel® Catheter

Arm Description

All eligible subjects will receive an Angel® Catheter.

Outcomes

Primary Outcome Measures

Number of Adverse Events Occuring for All Evaluable Subjects

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.

Secondary Outcome Measures

Device Performance

Full Information

NCT ID

NCT01847196

First Posted

May 2, 2013

Last Updated

August 14, 2015

Sponsor

BiO2 Medical

1. Study Identification

Unique Protocol Identification Number

NCT01847196

Brief Title

Angel® Catheter Early Feasibility Clinical Study

Official Title

A Multi-center, Early Feasibility Study of the Angel® Catheter in Critically Ill Subjects at High Risk of Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

IDE approval received for larger Pivotal Study

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BiO2 Medical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

STUDY ENDPOINTS 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. 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.

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

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

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Angel® Catheter

Arm Type

Experimental

Arm Description

All eligible subjects will receive an Angel® Catheter.

Intervention Type

Device

Intervention Name(s)

Angel® Catheter

Other Intervention Name(s)

Angel Catheter, 2011-0420

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Adverse Events Occuring for All Evaluable Subjects

Description

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.

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

Secondary Outcome Measure Information:

Title

Device Performance

Time Frame

From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA (Must Answer YES to all Inclusion Criteria): Subject or legally authorized representative is willing and able to provide written informed consent, AND Subject is 18 years or older, AND Subject is currently admitted OR to be admitted to the Intensive Care Unit (ICU) within ≤36 hours of screening, AND 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 Subject is considered at high risk for PE and meets ONE of the following criteria: 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 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 Critically ill subject requiring temporary (≥48 hours) interruption of medical thromboprophylaxis (prophylactic anticoagulation) EXCLUSION CRITERIA (Must Answer NO to All Exclusion Criteria): Subject is pregnant or lactating BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at http://nhlbisupport.com/bmi/bminojs.htm Subject has a pre-existing IVC filter in place 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. Subject has a diagnosis of pulmonary embolism Subject is participating in another clinical investigation Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium) 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 (including a history of thrombosis of venous system on side of proposed access) Anticipated survival ≤48 hours

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Schreiber, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Larry Martin, MD

Organizational Affiliation

University of Mississippi Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Holcomb, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Cripps, MD

Organizational Affiliation

University of Texas Southwestern Medical Center (Dallas)

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

University of Texas Southwestern Medical Center - Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9158

Country

United States

Facility Name

University of Texas Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Angel® Catheter Early Feasibility Clinical Study

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