Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

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

Translate

General Information

Age Group

Adults

Status

Enrolled by Invitation

Protocol Number

NCT03761173

Background Information

The primary study objective is 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.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Paul Butros, MD

Eligibility Information

  • Age ≥ 18 years
  • 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.

Ineligibility Information

  • Unable to anticoagulate 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 opinion of the Investigator, the patient is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location or predominately chronic clot) *
  • Life expectancy <30 days, as determined by the Investigator
  • Current participation in another 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

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03761173