Pulmonary

Recruiting

Baptist Health Louisville

Sreedevi Gondi

Principal Investigator

Karin Cryan

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Overview

FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Description

Adults 18+ requiring thrombectomy for pulmonary embolism (PE). 

Learn more at ClinicalTrials.gov.

Eligibility Criteria

Inclusion

Adults 18+ requiring thrombectomy for pulmonary embolism (PE).  Must present clinical signs and symptoms consistent with acute PE, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar artery, must be scheduled for PE treatment with the FlowTriever System per investigator's discretion.

Exclusion

  • 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