Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism
Condition: Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Angel Catheter
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Central Line Catheter; Vena Cava Filters

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