Clinical trial NCT01847196: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: BiO2 Medical
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Number of Adverse Events Occuring for All Evaluable Subjects
timeFrame: 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 outcomes:
measure: Device Performance
timeFrame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
Study officials:
affiliation: Oregon Health and Science University
name: Martin Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: Larry Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: John Holcomb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center (Dallas)
name: Michael Cripps, MD
role: PRINCIPAL_INVESTIGATOR
References: