Angel® Catheter Early Feasibility Clinical Study

• Sponsor: BiO2 Medical (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01847196
• Collaborator: (none)
• Enrollment: 6
• Locations: 4
• Arm: 1
• Duration (Months): 7
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.2

Study Details

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	N/A

Detailed Description

STUDY ENDPOINTS

1. Primary Endpoints:

1. 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.

1. 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
• 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: Nov 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 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 [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 [From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

6. 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

1. 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

1. 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.

1. Subject has a diagnosis of pulmonary embolism

2. Subject is participating in another clinical investigation

3. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)

4. Subject has functioning pelvic renal allograft on the only side available for device insertion

5. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted

6. Anatomic inability to place the Angel® Catheter (including a history of thrombosis of venous system on side of proposed access)

7. Anticipated survival ≤48 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BiO2 Medical
• ClinicalTrials.gov Identifier: NCT01847196
• Other Study ID Numbers: QD-155
• First Posted: May 6, 2013
• Last Update Posted: Aug 26, 2015
• Last Verified: Aug 1, 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

Study Results

Participant Flow

Pre-assignment Detail	For this study, enrollment was defined as the time of consent. There was a possibility that a consented subject could still become ineligible prior to Angel® Catheter placement. One (1) of the six (6) enrolled (i.e. consented) subjects became ineligible prior to Angel® Catheter placement, and did not go on to start the study.

Arm/Group Title	Angel® Catheter
Arm/Group Description	All eligible subjects received an 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.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Angel® Catheter
Arm/Group Description	All eligible subjects received an 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.
Overall Participants	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.2 (10.4)
Sex: Female, Male (Count of Participants)
Female	1 20%
Male	4 80%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.8 (4.5)
Trauma as Primary Reason for Hospital Admission (participants) [Number]
Number [participants]	5 100%
Baseline Venous Thromboembolism (participants) [Number]
No	5 100%
Yes	0 0%
Baseline Central Venous Catheter in Place (participants) [Number]
No	3 60%
Yes	2 40%
Subject on Mechanical Ventilation at Baseline (participants) [Number]
No	3 60%
Yes	2 40%
Subject on Vasopressors at Baseline (participants) [Number]
No	5 100%
Yes	0 0%
Subject on Dialysis at Baseline (participants) [Number]
No	5 100%
Yes	0 0%
Traumatic Brain Injury at Baseline (participants) [Number]
No	2 40%
Yes	3 60%
Subarachnoid and/or Subdural Bleeding at Baseline (participants) [Number]
No	3 60%
Yes	2 40%
Musculoskeletal Fractures at Baseline (participants) [Number]
No	1 20%
Yes	4 80%
Spinal Injury at Baseline (participants) [Number]
No	4 80%
Yes	1 20%
Respiratory Trauma or Distress at Baseline (participants) [Number]
No	1 20%
Yes	4 80%
Hepatic Trauma at Baseline (participants) [Number]
No	2 40%
Yes	3 60%
Multiple Fractures of Upper and Lower Limbs at Baseline (participants) [Number]
No	4 80%
Yes	1 20%
Spleen/Kidney Laceration at Baseline (participants) [Number]
No	3 60%
Yes	2 40%

Outcome Measures

1. Primary Outcome

Title	Number of Adverse Events Occuring for All Evaluable Subjects
Description	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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angel® Catheter
Arm/Group Description	All eligible subjects received an 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.
Measure Participants	5
Angel Catheter Related Thrombosis	0 0%
Angel Catheter Related Pulmonary Embolism	0 0%
Angel Catheter Related Blood Stream Infection	0 0%
Angel Catheter Related Deep Vein Thrombosis (DVT)	2 40%
Angel Catheter Related Major Bleeding	0 0%
Angel Catheter Related Catheter Movement >2cm	2 40%
Angel Catheter Related Vena Cava Perforation	0 0%
Angel Catheter Related Death	0 0%

2. Secondary Outcome

Title	Device Performance
Time Frame	From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angel® Catheter
Arm/Group Description	All eligible subjects received an 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.
Measure Participants	5
Total Number of Device Malfunctions	2
Device Malfunctions resulting in clinical harm	0

Adverse Events

Time Frame	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.
Arm/Group Title	Angel® Catheter
Arm/Group Description	All eligible subjects received an 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.
All Cause Mortality
	Angel® Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Angel® Catheter
	Affected / at Risk (%)	# Events
Total	2/5 (40%)
Hepatobiliary disorders
Perihepatic Fluid Collection	1/5 (20%)
Nervous system disorders
Intracranial Hypertension	1/5 (20%)
Respiratory, thoracic and mediastinal disorders
Inadequate Ventilation	1/5 (20%)
Respiratory Desaturation	1/5 (20%)
Vascular disorders
Deep Vein Thrombosis	2/5 (40%)
Other (Not Including Serious) Adverse Events
	Angel® Catheter
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Blood and lymphatic system disorders
Decreased Hemoglobin	1/5 (20%)
Decreased Phosphorus Level	1/5 (20%)
Decreased Potassium Level	1/5 (20%)
Increased Anemia	1/5 (20%)
Increased Platelets	1/5 (20%)
Increased Leukocytosis	1/5 (20%)
Gastrointestinal disorders
Constipation Related to Neurogenic Bowel	1/5 (20%)
Diarrhea	1/5 (20%)
Gastric Distention	1/5 (20%)
General disorders
Pain - Abdominal	2/5 (40%)
Pain - Back	1/5 (20%)
Pain - Flank	1/5 (20%)
Hepatobiliary disorders
Decreased Hepatic Function	1/5 (20%)
Respiratory, thoracic and mediastinal disorders
Abnormal Chest Sounds	1/5 (20%)
Pneumonia	1/5 (20%)
Respiratory Distress	1/5 (20%)
Tachycardia	1/5 (20%)
Tachypnea	1/5 (20%)
Surgical and medical procedures
Catheter Movement >2 cm	2/5 (40%)
Vascular disorders
Pulmonary Embolism	1/5 (20%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.