To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
Study Type
OBSERVATIONAL
Enrollment
1,200
Thrombectomy
Anticoagulation medication
Subjects With Major Adverse Events
MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.
Time frame: 48-hours after index procedure
Device-Related Mortality
Rate of subjects with device related mortality through 48 hours post index procedure
Time frame: 48-hours after the index procedure
Major Bleeding
Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products)
Time frame: 48 hours after index procedure
Intraprocedural Device-related or Procedure-related Adverse Events
Intraprocedural Device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury.
Time frame: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.
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UAB Division of Cardiovascular Disease
Birmingham, Alabama, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Lakeland Vascular Institute
Lakeland, Florida, United States
Palmetto General Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
...and 71 more locations