The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
Description
Brief Summary
The primary objective of this multicenter, prospective, single arm clinical trial is to
evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,
and with recognized contraindications to standard pharmacological therapy (anticoagulation).
Phase
N/AInclusion and Exclusion Criteria
- Subject or legally authorized representative is willing and able to provide written informed consent,
- Subject is 18 years or older,
- 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)
- 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
- Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
- Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
- Subject is pregnant
- Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
- Subject has a pre-existing IVC filter in place
- BMI = > 45
- Subject has functioning pelvic renal allograft on the only side available for device insertion
- Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
- Anatomic inability to place the Angel
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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