FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
NCT ID: NCT03761173
Last Updated: 2025-10-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2018-12-15
2024-09-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FlowTriever
Mechanical thrombectomy for pulmonary embolism
FlowTriever System
Thrombectomy
Conservative Therapy Sub-Study
Anticoagulation medication for pulmonary embolism (as directed by treating physician)
Anticoagulation Agents
Anticoagulation medication
Interventions
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FlowTriever System
Thrombectomy
Anticoagulation Agents
Anticoagulation medication
Eligibility Criteria
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Inclusion Criteria
* 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\*
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Catalin Toma, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UAB Division of Cardiovascular Disease
Birmingham, Alabama, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Lakeland Vascular Institute
Lakeland, Florida, United States
Palmetto General Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Medical Center of Florida
Miami, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Javon Bea Hospital
Rockford, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Norton Healthcare
Louisville, Kentucky, United States
Baptist Health Lousville
Louisville, Kentucky, United States
Opelousas General
Opelousas, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Ascension Genesys Hospital
Grand Blanc, Michigan, United States
Ascension Providence Hospital
Madison Heights, Michigan, United States
Ascension Providence Rochester Hospital
Rochester, Michigan, United States
Beaumont Health
Royal Oak, Michigan, United States
St. Joseph Mercy
Ypsilanti, Michigan, United States
Metropolitan Heart and Vascular Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, United States
University of Missouri, Columbia
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Lee's Summit, Missouri, United States
Valley Health
Ridgewood, New Jersey, United States
Albany Medical Center
Albany, New York, United States
SUNY, The University at Buffalo
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Jamaica Hospital
Queens, New York, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Methodist Healthcare Foundation
Germantown, Tennessee, United States
UTMC Knoxville
Knoxville, Tennessee, United States
St. Thomas West
Nashville, Tennessee, United States
CardioVoyage
Denison, Texas, United States
Inova Fairfax
Falls Church, Virginia, United States
Sentara
Norfolk, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Providence Sacred Heart
Spokane, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 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, , 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
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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18-002
Identifier Type: -
Identifier Source: org_study_id
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