Trial Outcomes & Findings for Angel® Catheter Early Feasibility Clinical Study (NCT NCT01847196)

NCT ID: NCT01847196

Last Updated: 2015-08-26

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome 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
• Results posted on: 2015-08-26

Participant Flow

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.

Participant milestones

Measure	Angel® Catheter 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 Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Angel® Catheter Early Feasibility Clinical Study

Baseline characteristics by cohort

Measure	Angel® Catheter n=5 Participants 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.
Age, Continuous	33.2 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Body Mass Index	25.8 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants
Trauma as Primary Reason for Hospital Admission	5 participants n=5 Participants
Baseline Venous Thromboembolism No	5 participants n=5 Participants
Baseline Venous Thromboembolism Yes	0 participants n=5 Participants
Baseline Central Venous Catheter in Place No	3 participants n=5 Participants
Baseline Central Venous Catheter in Place Yes	2 participants n=5 Participants
Subject on Mechanical Ventilation at Baseline No	3 participants n=5 Participants
Subject on Mechanical Ventilation at Baseline Yes	2 participants n=5 Participants
Subject on Vasopressors at Baseline No	5 participants n=5 Participants
Subject on Vasopressors at Baseline Yes	0 participants n=5 Participants
Subject on Dialysis at Baseline No	5 participants n=5 Participants
Subject on Dialysis at Baseline Yes	0 participants n=5 Participants
Traumatic Brain Injury at Baseline No	2 participants n=5 Participants
Traumatic Brain Injury at Baseline Yes	3 participants n=5 Participants
Subarachnoid and/or Subdural Bleeding at Baseline No	3 participants n=5 Participants
Subarachnoid and/or Subdural Bleeding at Baseline Yes	2 participants n=5 Participants
Musculoskeletal Fractures at Baseline No	1 participants n=5 Participants
Musculoskeletal Fractures at Baseline Yes	4 participants n=5 Participants
Spinal Injury at Baseline No	4 participants n=5 Participants
Spinal Injury at Baseline Yes	1 participants n=5 Participants
Respiratory Trauma or Distress at Baseline No	1 participants n=5 Participants
Respiratory Trauma or Distress at Baseline Yes	4 participants n=5 Participants
Hepatic Trauma at Baseline No	2 participants n=5 Participants
Hepatic Trauma at Baseline Yes	3 participants n=5 Participants
Multiple Fractures of Upper and Lower Limbs at Baseline No	4 participants n=5 Participants
Multiple Fractures of Upper and Lower Limbs at Baseline Yes	1 participants n=5 Participants
Spleen/Kidney Laceration at Baseline No	3 participants n=5 Participants
Spleen/Kidney Laceration at Baseline Yes	2 participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Measure	Angel® Catheter n=5 Participants 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.
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Thrombosis	0 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Pulmonary Embolism	0 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Blood Stream Infection	0 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Deep Vein Thrombosis (DVT)	2 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Major Bleeding	0 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Catheter Movement >2cm	2 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Vena Cava Perforation	0 participants
Number of Adverse Events Occuring for All Evaluable Subjects Angel Catheter Related Death	0 participants

SECONDARY outcome

Timeframe: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days

Outcome measures

Measure	Angel® Catheter n=5 Participants 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.
Device Performance Total Number of Device Malfunctions	2 device malfunctions
Device Performance Device Malfunctions resulting in clinical harm	0 device malfunctions

Adverse Events

Angel® Catheter

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Angel® Catheter n=5 participants at risk 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.
Vascular disorders Deep Vein Thrombosis	40.0% 2/5 • 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.
Respiratory, thoracic and mediastinal disorders Inadequate Ventilation	20.0% 1/5 • 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.
Hepatobiliary disorders Perihepatic Fluid Collection	20.0% 1/5 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Desaturation	20.0% 1/5 • 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.
Nervous system disorders Intracranial Hypertension	20.0% 1/5 • 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.

Other adverse events

Measure	Angel® Catheter n=5 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Abnormal Chest Sounds	20.0% 1/5 • 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.
Gastrointestinal disorders Constipation Related to Neurogenic Bowel	20.0% 1/5 • 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.
Blood and lymphatic system disorders Decreased Hemoglobin	20.0% 1/5 • 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.
Hepatobiliary disorders Decreased Hepatic Function	20.0% 1/5 • 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.
Blood and lymphatic system disorders Decreased Phosphorus Level	20.0% 1/5 • 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.
Blood and lymphatic system disorders Decreased Potassium Level	20.0% 1/5 • 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.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • 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.
Surgical and medical procedures Catheter Movement >2 cm	40.0% 2/5 • 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.
Gastrointestinal disorders Gastric Distention	20.0% 1/5 • 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.
Blood and lymphatic system disorders Increased Anemia	20.0% 1/5 • 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.
Blood and lymphatic system disorders Increased Platelets	20.0% 1/5 • 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.
Blood and lymphatic system disorders Increased Leukocytosis	20.0% 1/5 • 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.
General disorders Pain - Abdominal	40.0% 2/5 • 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.
General disorders Pain - Back	20.0% 1/5 • 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.
General disorders Pain - Flank	20.0% 1/5 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	20.0% 1/5 • 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.
Vascular disorders Pulmonary Embolism	20.0% 1/5 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	20.0% 1/5 • 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.
Respiratory, thoracic and mediastinal disorders Tachycardia	20.0% 1/5 • 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.
Respiratory, thoracic and mediastinal disorders Tachypnea	20.0% 1/5 • 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.

Additional Information

Margaret Tumas, VP of Clinical Affairs

BiO2 Medical

Phone: 720-635-3232

Email: mtumas@bio2medical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place