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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BiO2 Medical
ClinicalTrials.gov Identifier:
NCT01403090
First received: July 25, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Device: Angel Catheter
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by BiO2 Medical:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.


Enrollment: 8
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403090

Locations
Colombia
Clinica las Americas
Medellin, Antioquia, Colombia
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
  More Information

No publications provided

Responsible Party: BiO2 Medical
ClinicalTrials.gov Identifier: NCT01403090     History of Changes
Other Study ID Numbers: CPR-001
Study First Received: July 25, 2011
Results First Received: August 15, 2012
Last Updated: April 10, 2013
Health Authority: Colombia: National institute of Vigilance of Medications and Food (INVIMA)

Keywords provided by BiO2 Medical:
Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Central Line Catheter
Vena Cava Filters

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014