Status:
COMPLETED
Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism
Lead Sponsor:
BiO2 Medical
Conditions:
Pulmonary Embolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pre...
Eligibility Criteria
Inclusion
- Subject is 18 years and older
- Be admitted to the hospital
- One of the following two criteria:
- 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
- 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
- Patient is less than 18 years
- Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit
- Patient or next legal representative cannot give informed consent
- Patients with anticipated survival \< 2 days (catastrophic illness)
- Body mass index greater than 35
- Patient has a pre-existing filter
- Participation in another simultaneous interventional medical investigation or interventional trial.
- Patient has indications for a permanent filter at the time of the initial evaluation
- Patient has an uncontrollable coagulopathy with active bleeding.
- Patient with proven endocarditis or bacteremia
- Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol
- Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins
- Patient with functioning pelvic renal allograft on the only side available for device insertion
- Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01403090
Start Date
December 1 2011
End Date
March 1 2012
Last Update
May 20 2013
Active Locations (2)
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1
Clinica las Americas
Medellín, Antioquia, Colombia
2
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia