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

Inclusion criteria

• 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 criteria

• 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