Status:
COMPLETED
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
Lead Sponsor:
Inari Medical
Conditions:
PE - Pulmonary Embolism
PE - Pulmonary Thromboembolism
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Clinical signs and symptoms consistent with acute PE
- Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
- Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion\*
- US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
Exclusion
- Unable to be anticoagulated with heparin or alternative
- Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\*
- Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention\*
- Life expectancy \< 30 days, as determined by Investigator
- Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Key Trial Info
Start Date :
December 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03761173
Start Date
December 15 2018
End Date
September 4 2024
Last Update
October 1 2025
Active Locations (81)
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1
UAB Division of Cardiovascular Disease
Birmingham, Alabama, United States, 35294
2
University of Arizona College of Medicine
Tucson, Arizona, United States, 85719
3
Pima Heart and Vascular
Tucson, Arizona, United States, 85741
4
University of Colorado
Aurora, Colorado, United States, 80045