Status:
TERMINATED
Angel® Catheter Early Feasibility Clinical Study
Lead Sponsor:
BiO2 Medical
Conditions:
Pulmonary Embolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 event...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01847196
Start Date
November 1 2013
End Date
June 1 2014
Last Update
August 26 2015
Active Locations (4)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
2
Oregon Health and Science University
Portland, Oregon, United States, 97239
3
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9158
4
University of Texas Houston
Houston, Texas, United States, 77030