FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
FLASH
1 other identifier
observational
1,200
9 countries
81
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2024
CompletedResults Posted
Study results publicly available
October 1, 2025
CompletedOctober 1, 2025
September 1, 2025
5.7 years
November 28, 2018
September 11, 2025
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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, 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.
48-hours after index procedure
Secondary Outcomes (3)
Device-Related Mortality
48-hours after the index procedure
Major Bleeding
48 hours after index procedure
Intraprocedural Device-related or Procedure-related Adverse Events
Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.
Study Arms (2)
FlowTriever
Mechanical thrombectomy for pulmonary embolism
Conservative Therapy Sub-Study
Anticoagulation medication for pulmonary embolism (as directed by treating physician)
Interventions
Eligibility Criteria
Patients requiring treatment for pulmonary embolism.
You may qualify if:
- 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\*
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inari Medicallead
Study Sites (81)
UAB Division of Cardiovascular Disease
Birmingham, Alabama, 35294, United States
University of Arizona College of Medicine
Tucson, Arizona, 85719, United States
Pima Heart and Vascular
Tucson, Arizona, 85741, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06511, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Lakeland Vascular Institute
Lakeland, Florida, 33801, United States
Palmetto General Hospital
Miami, Florida, 33016, United States
University of Miami
Miami, Florida, 33125, United States
Mount Sinai Medical Center of Florida
Miami, Florida, 33140, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Emory University
Atlanta, Georgia, 30308, United States
Rush Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Northwestern University
Evanston, Illinois, 60208, United States
Javon Bea Hospital
Rockford, Illinois, 61103, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Norton Healthcare
Louisville, Kentucky, 40205, United States
Baptist Health Lousville
Louisville, Kentucky, 40207, United States
Opelousas General
Opelousas, Louisiana, 70570, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439, United States
Ascension Providence Hospital
Madison Heights, Michigan, 48334, United States
Ascension Providence Rochester Hospital
Rochester, Michigan, 48307, United States
Beaumont Health
Royal Oak, Michigan, 48073, United States
St. Joseph Mercy
Ypsilanti, Michigan, 48106, United States
Metropolitan Heart and Vascular Institute
Minneapolis, Minnesota, 55433, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201, United States
University of Missouri, Columbia
Columbia, Missouri, 65212, United States
Saint Luke's Hospital of Kansas City
Lee's Summit, Missouri, 64086, United States
Valley Health
Ridgewood, New Jersey, 07450, United States
Albany Medical Center
Albany, New York, 12208, United States
SUNY, The University at Buffalo
Buffalo, New York, 14203, United States
Northwell Health
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Mount Sinai
New York, New York, 10029, United States
Jamaica Hospital
Queens, New York, 11418, United States
St. Francis Hospital & Heart Center
Roslyn, New York, 11576, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Methodist Healthcare Foundation
Germantown, Tennessee, 38138, United States
UTMC Knoxville
Knoxville, Tennessee, 37920, United States
St. Thomas West
Nashville, Tennessee, 37205, United States
CardioVoyage
Denison, Texas, 75071, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
Sentara
Norfolk, Virginia, 23507, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Providence Sacred Heart
Spokane, Washington, 99204, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Allgemeines Krankenhaus AKH Wien
Vienna, Austria
UZ Antwerpen
Antwerp, Belgium
UZ Brussel
Brussels, Belgium
Centre Hospitalier Universitaire de Besançon
Besançon, France
Hopital de la Cavale Blanche - CHU Brest
Brest, France
CHU Grenoble
Grenoble, France
Institut Coeur Poumon - CHU de Lille
Lille, France
HCL Hôpital Louis Pradel - Hôpital Cardiologique
Lyon, France
European Hospital Georges Pompidou
Paris, France
Charité Hospital - Campus Virchow-Klinikum
Berlin, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
University Hospital
Heidelberg, Germany
Universitatsklinikum des Saarlandes
Homburg, Germany
Helios Kliniken Schwerin
Schwerin, Germany
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Clínico San Carlos
Madrid, 28040, Spain
Gregorio Maranon University Hospital
Madrid, Spain
Inselspital
Bern, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland
Unispital
Zurich, Switzerland
The Royal Free Hospital
London, United Kingdom
The Royal London Hospital, Bart's Health
London, United Kingdom
Related Publications (5)
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.
PMID: 39131977BACKGROUNDKhandhar 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.
PMID: 39131661BACKGROUNDBangalore 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.
PMID: 37100559BACKGROUNDToma 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.
PMID: 36349702BACKGROUNDToma 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.
PMID: 35114059BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ashleigh Willson
- Organization
- Inari Medical, Now Part of Stryker
Study Officials
- PRINCIPAL INVESTIGATOR
Catalin Toma, MD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 3, 2018
Study Start
December 15, 2018
Primary Completion
September 4, 2024
Study Completion
September 4, 2024
Last Updated
October 1, 2025
Results First Posted
October 1, 2025
Record last verified: 2025-09