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Completed

NCT Number: NCT03761173

FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

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).

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Key information

Conditions

PE - Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases PE - Pulmonary Thromboembolism Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus AKH Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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*
  • 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 criteria

  • 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

Treatment and study plan

FlowTriever System

Device

Thrombectomy

Anticoagulation Agents

Drug

Anticoagulation medication

Primary outcomes

  1. Subjects With Major Adverse Events

    Time frame: 48-hours after index procedure

    MAEs are defined as a composite, when one or more of the following events occur:

    • Device-related mortality through 48 hours after the index procedure, or
    • Major bleeding through 48 hours after the index procedure, or
    • Intra-procedural device-related or procedure-related adverse events, including:
    • Clinical deterioration defined by hemodynamic or respiratory worsening, or
    • Device-related pulmonary vascular injury, or
    • Device-related cardiac injury

    The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.

Secondary outcomes

  1. Device-Related Mortality

    Time frame: 48-hours after the index procedure

    Rate of subjects with device related mortality through 48 hours post index procedure

  2. Major Bleeding

    Time frame: 48 hours after index procedure

    Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products)

  3. Intraprocedural Device-related or Procedure-related Adverse Events

    Time frame: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.

    Intraprocedural Device-related or procedure-related adverse events, including:

    • Clinical deterioration defined by hemodynamic or respiratory worsening, or
    • Device-related pulmonary vascular injury, or
    • Device-related cardiac injury.

Sponsors and collaborators

Lead sponsor

Inari Medical

Industry

Registry information

Official study title

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

Acronym: FLASH

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2018
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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