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

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403090
• Other study ID #: CPR-001
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2011
• Last updated: April 10, 2013
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: BiO2 Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: National institute of Vigilance of Medications and Food (INVIMA)
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Colombia	Clinica las Americas	Medellin	Antioquia
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
BiO2 Medical

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.	30 days	Yes