Clinical trial NCT01403090: Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Keywords: Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Central Line Catheter
Vena Cava Filters
Lead sponsor: BiO2 Medical
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 .


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

Primary outcomes:
measure: Safety
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica las Americas
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
Study officials:
affiliation: Hospital Pablo Tobon Uribe
name: Carlos Cadavid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Las Americas
name: Bladimir Gil, MD
role: PRINCIPAL_INVESTIGATOR
References: