Angel® Catheter Early Feasibility Clinical Study

• ClinicalTrials.gov Identifier: NCT01847196
• Recruitment Status: Terminated
• First Posted: May 6, 2013
• Results First Posted: August 14, 2015
• Last Update Posted: August 26, 2015
• Sponsor: BiO2 Medical
• Information provided by (Responsible Party): BiO2 Medical

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism	Device: Angel® Catheter	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: November 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Device Performance [ Time Frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: BiO2 Medical
• ClinicalTrials.gov Identifier: NCT01847196
• Other Study ID Numbers: QD-155
• First Posted: May 6, 2013
• Results First Posted: August 14, 2015
• Last Update Posted: August 26, 2015
• Last Verified: August 2015

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:

Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases