FLARE

Condition: Pulmonary embolism

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Clinical signs, symptoms and presentation consistent with acute pulmonary embolism
  • Pulmonary embolism symptom duration less than or equal to 14 days
  • Computed tomography angiography evidence of proximal pulmonary embolism

Key Exclusion Criteria

  • Thrombolytic use within 30 days of baseline computed tomography angiography
  • Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization
  • Vasopressor requirement after fluids to keep pressure ≥90 mmHg

Full Study Name

FlowTriever Pulmonary Embolectomy Clinical Study (IRB no. 43583)

Summary

This study focuses on individuals diagnosed with a pulmonary embolism (blood clot) that is trapped within the lungs. The purpose of the study is to evaluate the safety and effectiveness of the FlowTriever Aspiration System (referred to as “FlowTriever System”) for removing blood clots from pulmonary arteries (vessels that transport blood from the heart to the lungs). The FlowTriever System is a medical device that is used to trap the clot and pull it into a thin tube (catheter) so that the clot can be removed from the body. The device has been approved by the U.S. Food and Drug Administration for removing emboli and thrombi (blood clots) from blood vessels, but its use in this study is investigational.

Principal Investigator

Victor Tapson, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org