IDE approval received for larger Pivotal Study

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.

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.

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

For all subjects in whom Angel Catheter placement was attempted, all Adverse Events were collected from the time of enrollment (i.e. consent) through study exit (i.e. after 7 days of post-removal follow-up or at hospital discharge), for up to 37 days.

Due to the small number of patients, analysis is descriptive only.