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

April 15, 2024 updated by: Inari Medical

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Allgemeines Krankenhaus AKH Wien
  • Belgium
      • Antwerpen, Belgium
        • UZ Antwerpen
      • Brussel, 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 Maranon University Hospital
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Saint Gallen, Switzerland
        • Kantonsspital Sankt Gallen
      • Zürich, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Composite Major Adverse Events
Time Frame: 48-hours
Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events
48-hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual Major Adverse Events
Time Frame: 48-hours
Rate of subjects with individual components of composite MAE
48-hours
All-cause mortality
Time Frame: 30-days
Rate of deaths
30-days
Device-related serious adverse events
Time Frame: 30-days
Rate of device-related SAEs
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inari Medical

Investigators

  • Principal Investigator: Catalin Toma, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2018

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 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 (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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