Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
1. Subject or legally authorized representative is willing and able to provide written informed consent,
2. Subject is 18 years or older,
3. Subject is expected to remain in a critical care setting for at least 72 hours, AND at least one of the following inclusion criteria (4,5, and/or 6)
4. Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
- Active bleeding or at high risk for bleeding OR
- Hypersensitivity to pharmacological thromboprophylaxis OR
- History of severe heparin induced thrombocytopenia OR
- Severe thrombocytopenia
5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
6. Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
Exclusion Criteria:
1. Subject is pregnant
2. Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
3. Subject has a pre-existing IVC filter in place
4. BMI ≥ 45
5. Subject has functioning pelvic renal allograft on the only side available for device insertion
6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
7. Anatomic inability to place the Angel® Catheter
8. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)