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

A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism

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 .

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Device: Angel Catheter

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Pablo Tobon Uribe
    • Medellin, Antioquia, Colombia
      • Clínica Las Américas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BiO2 Medical
• Investigators: Principal Investigator: Carlos Cadavid, MD, Hospital Pablo Tobon Uribe; Principal Investigator: Bladimir Gil, MD, Clínica Las Américas

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism; Vena Cava Filters; Central Line Catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: CPR-001