Clinical trial NCT03761173: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
Official title: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PE - Pulmonary Embolism
PE - Pulmonary Thromboembolism
Keywords: PE
pulmonary embolism
thromboembolism
thrombectomy
FlowTriever
Anticoagulation Medication
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 1186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring treatment for pulmonary embolism.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Composite Major Adverse Events
timeFrame: 48-hours
Secondary outcomes:
measure: Individual Major Adverse Events
timeFrame: 48-hours
measure: All-cause mortality
timeFrame: 30-days
measure: Device-related serious adverse events
timeFrame: 30-days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Division of Cardiovascular Disease
state: Alabama
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Lakeland Vascular Institute
state: Florida
city: Miami
country: United States
facility: Palmetto General Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Rockford
country: United States
facility: Javon Bea Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Lousville
state: Kentucky
city: Opelousas
country: United States
facility: Opelousas General
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Blanc
country: United States
facility: Ascension Genesys Hospital
state: Michigan
city: Madison Heights
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Rochester
country: United States
facility: Ascension Providence Rochester Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy
state: Michigan
city: Minneapolis
country: United States
facility: Metropolitan Heart and Vascular Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Columbia
country: United States
facility: University of Missouri, Columbia
state: Missouri
city: Lee's Summit
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Ridgewood
country: United States
facility: Valley Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: SUNY, The University at Buffalo
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Queens
country: United States
facility: Jamaica Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital & Heart Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Germantown
country: United States
facility: Methodist Healthcare Foundation
state: Tennessee
city: Knoxville
country: United States
facility: UTMC Knoxville
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas West
state: Tennessee
city: Denison
country: United States
facility: CardioVoyage
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Norfolk
country: United States
facility: Sentara
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH Wien
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Brussel
country: Belgium
facility: UZ Brussel
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Brest
country: France
facility: Hopital de la Cavale Blanche - CHU Brest
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Institut Coeur Poumon - CHU de Lille
city: Lyon
country: France
facility: HCL Hôpital Louis Pradel - Hôpital Cardiologique
city: Paris
country: France
facility: European Hospital Georges Pompidou
city: Berlin
country: Germany
facility: Charité Hospital - Campus Virchow-Klinikum
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Heidelberg
country: Germany
facility: University Hospital
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Gregorio Maranon University Hospital
city: Bern
country: Switzerland
facility: Inselspital
city: Saint Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Zürich
country: Switzerland
facility: Unispital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital, Bart's Health
Study officials:
affiliation: University of Pittsburgh
name: Catalin Toma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.