Trial Outcomes & Findings for Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism (NCT NCT01403090)

Results Overview

Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

30 days

Results posted on

2013-05-20

Participant Flow

Recruitment started at the Hospital Pablo Tobon Uribe and was then followed at the clinical las Americas. Eight patients were recruited in the initial phase of the study

Participant milestones

Participant milestones
Measure	Angel Catheter Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Angel Catheter n=8 Participants Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	35.4 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Colombia	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.

Outcome measures

Outcome measures
Measure	Angel Catheter n=8 Participants Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
Safety	0 participants

Adverse Events

Angel Catheter

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Angel Catheter n=8 participants at risk
Infections and infestations Death	12.5% 1/8 • Number of events 1
Vascular disorders Deep Vein Thrombosis	12.5% 1/8 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Luis Angel, MD

BiO2 medical

Phone: 2102139778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60