Cardiology

Recruiting

Baptist Health Louisville

Sreedevi Gondi

Principal Investigator

Karin Cryan

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Flash: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
Description

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.

Learn more at ClinicalTrials.gov.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to be anticoagulated with heparin or alternative
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