PE - Pulmonary EmbolismFLASHNCT03761173
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
An observational study of PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism, run by Inari Medical at 81 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
- What is being tested?
- FlowTriever System and Anticoagulation Agents
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 81 sitesin 9 countries
- Study dates
- 15 Dec 2018to 4 Sep 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring treatment for pulmonary embolism.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
81 sites in 9 countries.
81 sites in 9 countries
United States59 sites
Albany Medical Center
Albany, New York, 12208
Emory University
Atlanta, Georgia, 30308
University of Colorado
Aurora, Colorado, 80045
UAB Division of Cardiovascular Disease
Birmingham, Alabama, 35294
SUNY, The University at Buffalo
Buffalo, New York, 14203
Rush Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201
University of Missouri, Columbia
Columbia, Missouri, 65212
CardioVoyage
Denison, Texas, 75071
Henry Ford Health System
Detroit, Michigan, 48202
Northwestern University
Evanston, Illinois, 60208
Providence Regional Medical Center Everett
Everett, Washington, 98201
Inova Fairfax
Falls Church, Virginia, 22042
Methodist Healthcare Foundation
Germantown, Tennessee, 38138
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
UTMC Knoxville
Knoxville, Tennessee, 37920
Lakeland Vascular Institute
Lakeland, Florida, 33801
Saint Luke's Hospital of Kansas City
Lee's Summit, Missouri, 64086
Norton Healthcare
Louisville, Kentucky, 40205
Baptist Health Lousville
Louisville, Kentucky, 40207
Ascension Providence Hospital
Madison Heights, Michigan, 48334
Northwell Health
Manhasset, New York, 11030
Palmetto General Hospital
Miami, Florida, 33016
University of Miami
Miami, Florida, 33125
Mount Sinai Medical Center of Florida
Miami, Florida, 33140
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Metropolitan Heart and Vascular Institute
Minneapolis, Minnesota, 55433
University of Minnesota
Minneapolis, Minnesota, 55455
St. Thomas West
Nashville, Tennessee, 37205
Yale University
New Haven, Connecticut, 06511
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai
New York, New York, 10029
Christiana Care Health Services
Newark, Delaware, 19713
Sentara
Norfolk, Virginia, 23507
Opelousas General
Opelousas, Louisiana, 70570
Ascension Sacred Heart
Pensacola, Florida, 32504
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jamaica Hospital
Queens, New York, 11418
Valley Health
Ridgewood, New Jersey, 07450
Ascension Providence Rochester Hospital
Rochester, Michigan, 48307
Javon Bea Hospital
Rockford, Illinois, 61103
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
Beaumont Health
Royal Oak, Michigan, 48073
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Providence Sacred Heart
Spokane, Washington, 99204
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
University of Arizona College of Medicine
Tucson, Arizona, 85719
Pima Heart and Vascular
Tucson, Arizona, 85741
Westchester Medical Center
Valhalla, New York, 10595
Lexington Medical Center
West Columbia, South Carolina, 29169
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
St. Joseph Mercy
Ypsilanti, Michigan, 48106
France6 sites
Centre Hospitalier Universitaire de Besançon
Besançon
Hopital de la Cavale Blanche - CHU Brest
Brest
CHU Grenoble
Grenoble
Institut Coeur Poumon - CHU de Lille
Lille
HCL Hôpital Louis Pradel - Hôpital Cardiologique
Lyon
European Hospital Georges Pompidou
Paris
Germany5 sites
Charité Hospital - Campus Virchow-Klinikum
Berlin
Cardioangiologisches Centrum Bethanien
Frankfurt
University Hospital
Heidelberg
Universitatsklinikum des Saarlandes
Homburg
Helios Kliniken Schwerin
Schwerin
Switzerland3 sites
Inselspital
Bern
Kantonsspital Sankt Gallen
Sankt Gallen
Unispital
Zurich
Spain2 sites
Hospital Clínico San Carlos
Madrid, 28040
Gregorio Maranon University Hospital
Madrid
United Kingdom2 sites
The Royal Free Hospital
London
The Royal London Hospital, Bart's Health
London
About this study
Official title: 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).
- Being tested
- FlowTriever System, Anticoagulation Agents
- Keywords
- PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
- Medical subject headings
- Pulmonary Embolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowTriever SystemDevice
Thrombectomy
Anticoagulation AgentsDrug
Anticoagulation medication
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever | Mechanical thrombectomy for pulmonary embolism Receives: Device: FlowTriever System | |
| Conservative Therapy Sub-Study | Anticoagulation medication for pulmonary embolism (as directed by treating physician) Receives: Drug: Anticoagulation Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48-hours after index procedure
Secondary outcomes (3)
Device-Related Mortality
Rate of subjects with device related mortality through 48 hours post index procedure
Measured: 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)
Measured: 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.
Measured: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start15 Dec 2018
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PE - Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catalin Toma, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761173
- Sponsor's protocol ID
- 18-002
- Acronym
- FLASH
- Status last verified
- Sep 2025
- First submitted
- 28 Nov 2018
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39131977Khandhar 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.
PubMed 39131661Bangalore 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.
PubMed 37100559Toma 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.
PubMed 36349702Toma 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.
PubMed 35114059
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
- ClinicalTrials.gov ID
- NCT03761173
- Acronym / sponsor ID
- FLASH / 18-002
- Keywords
- PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlowTriever | – | Device: FlowTriever SystemMechanical thrombectomy for pulmonary embolism |
| Conservative Therapy Sub-Study | – | Drug: Anticoagulation AgentsAnticoagulation medication for pulmonary embolism (as directed by treating physician) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring treatment for pulmonary embolism.
Key inclusion criteria (4 listed)
- 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*
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowTriever SystemThrombectomy | Device | FlowTriever |
| Anticoagulation AgentsAnticoagulation medication | Drug | Conservative Therapy Sub-Study |
Primary outcome
Subjects With Major Adverse Events
Time frame: 48-hours after index procedure
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.
3 secondary outcomes
Device-Related Mortality
Time frame: 48-hours after the index procedure
Major Bleeding
Time frame: 48 hours after index procedure
Intraprocedural Device-related or Procedure-related Adverse Events
Time frame: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39131977Horowitz 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.
- Background: PubMed 39131661Khandhar 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.
- Background: PubMed 37100559Bangalore 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.
- Background: PubMed 36349702Toma 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.
- Background: PubMed 35114059Toma 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catalin Toma, MD principal investigator
University of Pittsburgh
81 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism, run by Inari Medical at 81 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, France, Germany, Switzerland, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With Major Adverse Events (time frame: 48-hours after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761173, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.