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

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

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).

Study Overview

• Status: Completed
• Conditions: PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism
• Intervention / Treatment: Device: FlowTriever System; Drug: Anticoagulation Agents

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Allgemeines Krankenhaus AKH Wien
• Belgium
  • Antwerp, Belgium
    • UZ Antwerpen
  • Brussels, Belgium
    • UZ Brussel
• France
  • Besançon, France
    • CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON
  • Brest, France
    • Hopital de la Cavale Blanche - CHU Brest
  • Grenoble, France
    • CHU Grenoble
  • Lille, France
    • Institut Coeur Poumon - CHU de Lille
  • Lyon, France
    • HCL Hôpital Louis Pradel - Hôpital Cardiologique
  • Paris, France
    • European Hospital Georges Pompidou
• Germany
  • Berlin, Germany
    • Charité Hospital - Campus Virchow-Klinikum
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Heidelberg, Germany
    • University Hospital
  • Homburg, Germany
    • Universitätsklinikum des Saarlandes
  • Schwerin, Germany
    • Helios Kliniken Schwerin
• Netherlands
  • Utrecht, Netherlands
    • Universitair Medisch Centrum Utrecht
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Gregorio Marañón University Hospital
• Switzerland
  • Bern, Switzerland
    • Inselspital
  • Sankt Gallen, Switzerland
    • Kantonsspital Sankt Gallen
  • Zurich, Switzerland
    • Unispital
• United Kingdom
  • London, United Kingdom
    • The Royal Free Hospital
  • London, United Kingdom
    • The Royal London Hospital, Bart's Health
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Division of Cardiovascular Disease
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona College of Medicine
    • Tucson, Arizona, United States, 85741
      • Pima Heart and Vascular
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Services
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Lakeland, Florida, United States, 33801
      • Lakeland Vascular Institute
    • Miami, Florida, United States, 33125
      • University of Miami
    • Miami, Florida, United States, 33016
      • Palmetto General Hospital
    • Miami, Florida, United States, 33140
      • Mount Sinai Medical Center of Florida
    • Pensacola, Florida, United States, 32504
      • Ascension Sacred Heart
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
    • Evanston, Illinois, United States, 60208
      • Northwestern University
    • Rockford, Illinois, United States, 61103
      • Javon Bea Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Norton Healthcare
    • Louisville, Kentucky, United States, 40207
      • Baptist Health Lousville
  • Louisiana
    • Opelousas, Louisiana, United States, 70570
      • Opelousas General
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Grand Blanc, Michigan, United States, 48439
      • Ascension Genesys Hospital
    • Madison Heights, Michigan, United States, 48334
      • Ascension Providence Hospital
    • Rochester, Michigan, United States, 48307
      • Ascension Providence Rochester Hospital
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health
    • Ypsilanti, Michigan, United States, 48106
      • St. Joseph Mercy
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55433
      • Metropolitan Heart and Vascular Institute
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Cardiovascular Specialists
    • Columbia, Missouri, United States, 65212
      • University of Missouri, Columbia
    • Lee's Summit, Missouri, United States, 64086
      • Saint Luke's Hospital of Kansas City
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Valley Health
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • SUNY, The University at Buffalo
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai
    • Queens, New York, United States, 11418
      • Jamaica Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital & Heart Center
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Methodist Healthcare Foundation
    • Knoxville, Tennessee, United States, 37920
      • UTMC Knoxville
    • Nashville, Tennessee, United States, 37205
      • St. Thomas West
  • Texas
    • Denison, Texas, United States, 75071
      • Cardiovoyage
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax
    • Norfolk, Virginia, United States, 23507
      • Sentara
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring treatment for pulmonary embolism.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FlowTriever; Mechanical thrombectomy for pulmonary embolism	Device: FlowTriever System; Thrombectomy
Conservative Therapy Sub-Study; Anticoagulation medication for pulmonary embolism (as directed by treating physician)	Drug: Anticoagulation Agents; Anticoagulation medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Major Adverse Events	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, orDevice-related pulmonary vascular injury, orDevice-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.	48-hours after index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-Related Mortality	Rate of subjects with device related mortality through 48 hours post index procedure	48-hours after the index procedure
Major Bleeding	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)	48 hours after index procedure
Intraprocedural Device-related or Procedure-related Adverse Events	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.	Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.

Collaborators and Investigators

• Sponsor: Inari Medical
• Investigators: Principal Investigator: Catalin Toma, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Bangalore S, Horowitz JM, Beam D, Jaber WA, Khandhar S, Toma C, Weinberg MD, Mina B. Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry. JACC Cardiovasc Interv. 2023 Apr 24;16(8):958-972. doi: 10.1016/j.jcin.2023.02.004.
• Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandhar S, Stegman B, Gondi S, Chambers J, Amin R, Leung DA, Kado H, Brown MA, Sarosi MG, Bhat AP, Castle J, Savin M, Siskin G, Rosenberg M, Fanola C, Horowitz JM, Pollak JS. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732.
• Toma C, Bunte MC, Cho KH, Jaber WA, Chambers J, Stegman B, Gondi S, Leung DA, Savin M, Khandhar S, Kado H, Koenig G, Weinberg M, Beasley RE, Roberts J, Angel W, Sarosi MG, Qaqi O, Veerina K, Brown MA, Pollak JS. Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1345-1355. doi: 10.1002/ccd.30091. Epub 2022 Feb 3.
• Horowitz JM, Jaber WA, Stegman B, Rosenberg M, Fanola C, Bhat AP, Gondi S, Castle J, Ahmed M, Brown MA, Amin R, Bisharat M, Butros P, DuCoffe A, Savin M, Pollak JS, Weinberg MD, Brancheau D, Toma C. Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry. J Soc Cardiovasc Angiogr Interv. 2023 Oct 31;3(1):101124. doi: 10.1016/j.jscai.2023.101124. eCollection 2024 Jan.
• Khandhar S, Jaber W, Bunte MC, Cho K, Weinberg MD, Mina B, Stegman B, Pollak J, Khosla A, Elmasri F, Zlotnick D, Brancheau D, Koenig G, Bisharat M, Li J, Toma C. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results. J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(4):101000. doi: 10.1016/j.jscai.2023.101000. eCollection 2023 Jul-Aug.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): September 4, 2024

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: thromboembolism; PE; pulmonary embolism; thrombectomy; FlowTriever; Anticoagulation Medication
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Thromboembolism; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hematologic Agents; Anticoagulants
• Other Study ID Numbers: 18-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No