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

NCT ID: NCT01403090

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-03-31

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 .

Conditions

Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Angel Catheter

Group Type: EXPERIMENTAL

Angel Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is 18 years and older

2. Be admitted to the hospital

One of the following two criteria:

3. 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

4. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BiO2 Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Cadavid, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Pablo Tobon Uribe

Bladimir Gil, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Las Americas

Locations

Clinica las Americas

Medellín, Antioquia, Colombia

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Countries

Colombia

Other Identifiers

CPR-001

Identifier Type: -

Identifier Source: org_study_id