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

Study ID
STU 062013-061

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • Parkland Health & Hospital System

Contact
Victoria Warren
214-648-2387
victoria.warren@utsouthwestern.edu

Principal Investigator
Michael Cripps

Summary

The angel[TM] Catheter is inserted at the bedside via the femoral vein, in the same manner as a conventional central venous catheter. The device incorporates a 3-lumen central venous catheter together with an inferior vena
cava filter, permanently attached, to the catheter that can be deployed and removed. Participation in this study will last up to one week after removal of the angel[TM] Catheter or discharge from the hospital (whichever is first). The device is intended for short-term use (less than 30 days).
Study event Sequence:
1. informed Consent
2. enrollment
3. Screening
4. Baseline Laboratory Tests (no more than 36 hours before angel[TM] Catheter insertion)
5. Duplex Doppler ultrasound of the lower extremeties and the iliofemoral segment will be performed within 24 hours before removal of angel[TM] Catheter
6. angel[TM] Catheter placement using ultrasound guidance
7. KuB immediately after angel[TM] Catheter placement and, if required, again after repositioning of the device
8. Daily assessments while angel[TM] Catheter is in place, including days of device insertion and removal
9. Duplex Doppler ultrasound of the lower extremeties and the iliofemoral segment within 24 hours of angel[TM] Catheter insertion
10. at the time of pre-removal, fluoroscopic imaging, spot films will be obtained of the filter to confirm proper positioning and filter integrity.
11. Venogram through Pigtail Catheter will be performed immediately prior to removal of the angel[TM]Catheter, utilize a Pigtail catheter to perform a vena cavagram, including as much of the iliocaval segment as possible, to check for thrombus burden
12. Vena Cavagram through angel Catheter Proximal Sheath Port will be completed immediately prior to removal of the angel Catheter. The Proximal Sheath port will be used to perform a vana cavagram to check for thrombus burden and to compare to the images obtained via the pigtail vena cavagram.
13. During the withdrawal of the angel Catheter (to the femoral access point) fluoroscopy loops will be obtained
14. With the angel Catheter positioned in the iliofemoral segment, utillize the angel Catheter Distal Tip Port to perform a venogram of the iliocaval segment
15.if the investigator determines that the veogram performed through the angel Catheter is insufficient to complete the necessary assessments, a Pigtail catheter will be utilized to perform an additional venogram
16. angel[TM] Catheter removal (within [Less Than] 30 days of placement)
17. if thrombus burden was detected prior to removal, a CT pulmonary angiogram will be performed after removal of the angel[TM] Catheter
18. Post-Removal Laboratory Tests (no more than 36 hours after angel[TM] Catheter Removal)
19. Duplex Doppler ultrasound of the lower extremeties and the iliofemoral segment will be performed within 24 hours before removal of the angel[TM] Catheter
20. Daily assessments continued post-removal for one week or until subject is discharged
21. Study exit (after seven post-removal follow-up visits have been completed, or at hospital discharge)

Participant Eligibility

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(TM) Catheter placement, AND
5. Subject is considered at high risk for PE and meets ONE of the following criteria:
5a. Subject has multiple trauma with at least ONE of the
following:
5a.1. Severe head injury
5a.2. Head injury with a long bone fracture
5a.3. Spinal cord injury with paraplegia or quadriplegia
5a.4. Multiple (>=2) long bone fractures
5a.5. Multiple (>=2) long bone fractures with pelvic fracture
5a.6. Pelvic fracture requiring open fixation
5b. Critically ill subject in the Intensive Care Unit with at least ONE of the following:
5b.1. Hemorrhagic or ischemic stroke
5b.2. Multiple organ failure
5b.3. Active or recent bleeding (within the past 2 weeks)
5b.4. Severe sepsis
5b.5. Lower extremity DVT
5b.6. Anticipated ventilator requirement of greater than one week
5c. Critically ill subject requiring temporary (>=48 hours) interruption of medical thromboprophylaxis (prophylactic anticoagulation)