FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

Completed

Conditions studied: PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

In brief

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).

Key facts

Study ID

NCT03761173

Run by

Inari Medical

People needed

1200

Starts

2018-12-15

Expected to finish

2024-09-04

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Mount Sinai Medical Center of Florida — Miami, Florida, United States
• Ascension Sacred Heart — Pensacola, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Javon Bea Hospital — Rockford, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Baptist Health Lousville — Louisville, Kentucky, United States
• Opelousas General — Opelousas, Louisiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Ascension Genesys Hospital — Grand Blanc, Michigan, United States
• UAB Division of Cardiovascular Disease — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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