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

• Sponsor: BiO2 Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01403090
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arm: 1
• Duration (Months): 3
• Patients Per Site: 4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. 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 primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism	Device: Angel Catheter	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Angel Catheter	Device: Angel Catheter; 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.

Outcome Measures

Primary Outcome Measures

1. Safety [30 days]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subject is 18 years and older

2. Be admitted to the hospital

One of the following two criteria:

1. Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:

• Contraindications for anticoagulation

• Recurrent PE despite adequate anticoagulation

• Emergency treatment following massive pulmonary embolism

1. Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:

• Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation

• severe head injury with coma

• severe hemorrhagic stroke with coma

• head injury with a long bone fracture

• spinal cord injury with paraplegia or quadriplegia

• multiple (≥2) long bone fractures with pelvic fracture

• multiple (≥4) long bone fractures

• Critically ill patients in the Medical or Surgical Intensive Care Unit with high risk of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter

• Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central

Exclusion Criteria:

1. Patient is less than 18 years

2. Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit

3. Patient or next legal representative cannot give informed consent

4. Patients with anticipated survival < 2 days (catastrophic illness)

5. Body mass index greater than 35

6. Patient has a pre-existing filter

7. Participation in another simultaneous interventional medical investigation or interventional trial.

8. Patient has indications for a permanent filter at the time of the initial evaluation

9. Patient has an uncontrollable coagulopathy with active bleeding.

10. Patient with proven endocarditis or bacteremia

11. Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol

12. Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins

13. Patient with functioning pelvic renal allograft on the only side available for device insertion

14. Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica las Americas	Medellin	Antioquia	Colombia
2	Hospital Pablo Tobon Uribe	Medellin	Antioquia	Colombia

Sponsors and Collaborators

• BiO2 Medical

Investigators

• Principal Investigator: Carlos Cadavid, MD, Hospital Pablo Tobon Uribe
• Principal Investigator: Bladimir Gil, MD, Clinica Las Americas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BiO2 Medical
• ClinicalTrials.gov Identifier: NCT01403090
• Other Study ID Numbers: CPR-001
• First Posted: Jul 27, 2011
• Last Update Posted: May 20, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by BiO2 Medical: Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Central Line Catheter; Vena Cava Filters
• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Angel Catheter
Arm/Group Description	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.
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Angel Catheter
Arm/Group Description	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 Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.4 (16.2)
Sex: Female, Male (Count of Participants)
Female	1 12.5%
Male	7 87.5%
Region of Enrollment (participants) [Number]
Colombia	8 100%

Outcome Measures

1. Primary Outcome

Title	Safety
Description	Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angel Catheter
Arm/Group Description	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.
Measure Participants	8
Number [participants]	0 0%

Adverse Events

Arm/Group Title	Angel Catheter
Arm/Group Description
All Cause Mortality
	Angel Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Angel Catheter
	Affected / at Risk (%)	# Events
Total	2/8 (25%)
Infections and infestations
Death	1/8 (12.5%)	1
Vascular disorders
Deep Vein Thrombosis	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Angel Catheter
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.