PE - Pulmonary EmbolismFLAMENCT04795167
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
An observational study of PE - Pulmonary Embolism and PE - Pulmonary Thromboembolism, run by Inari Medical at 11 sites in United States.
Trial summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism 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
- How many people
- 115 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Mar 2021to 19 Dec 2022
- 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 with high-risk (massive) pulmonary embolism.
Who may be able to join
- Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Who cannot join
- Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
- Witnessed cardiac arrest with ongoing CPR >30 minutes
- Contraindication to anticoagulants, i.e. heparin or alternative
- Hematocrit <28%
- Platelets <25,000/μL
- INR >8
Show all 12Show fewer
- Intracardiac thrombus and/or intracardiac clot in transit
- Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
- History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg
- Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
- Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University
Atlanta, Georgia, 30308
Gates Vascular Institute / SUNY Buffalo
Buffalo, New York, 14203
OhioHealth Riverside
Columbus, Ohio, 43214
Inova Fairfax
Falls Church, Virginia, 22042
Lenox Hill Hospital / Northwell Health
New York, New York, 10075
Penn Presbyterian/Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC
Pittsburgh, Pennsylvania, 15213
Beaumont Royal Oak
Royal Oak, Michigan, 48073
Ascension Providence Hospital
Southfield, Michigan, 48075
Lankenau Medical Center / Pulmonology Associates
Wynnewood, Pennsylvania, 19076
About this study
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
- Keywords
- PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, massive pulmonary embolism, high risk pulmonary embolism
- 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.
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever Arm | FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism. | |
| Context Arm | Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies. | |
| Prior Therapy Arm | Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%.
Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Secondary outcomes (7)
All-Cause Mortality
Incidence of mortality
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Bailout to an Alternative Thrombus Removal Strategy
Incidence of bailout to an alternative thrombus removal strategy
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Clinical Deterioration
Incidence of clinical deterioration
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Major Bleeding
Incidence of major bleeding
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Frequency of Stroke
Incidence of ischemic or hemorrhagic stroke
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Device-related Complications
Incidence of device-related complications
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Access Site Injury Requiring Intervention, Both Venous and Arterial
Incidence of access site injury requiring intervention, including both venous and arterial
Measured: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start16 Mar 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
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 (1)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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Silver, MD, Principal investigator, OhioHealth RiversideJames Horowitz, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795167
- Sponsor's protocol ID
- 20-001
- Acronym
- FLAME
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2021
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.
PubMed 37847768
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
- ClinicalTrials.gov ID
- NCT04795167
- Acronym / sponsor ID
- FLAME / 20-001
- Keywords
- PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, massive pulmonary embolism, high risk pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FlowTriever Arm | – | –FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism. |
| Context Arm | – | –Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies. |
| Prior Therapy Arm | – | –Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk (massive) pulmonary embolism.
Key inclusion criteria (1 listed)
- Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Key exclusion criteria (12 listed)
- Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
- Witnessed cardiac arrest with ongoing CPR >30 minutes
- Contraindication to anticoagulants, i.e. heparin or alternative
- Hematocrit <28%
- Platelets <25,000/μL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
7 secondary outcomes
All-Cause Mortality
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Bailout to an Alternative Thrombus Removal Strategy
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Clinical Deterioration
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Major Bleeding
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Frequency of Stroke
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Device-related Complications
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Access Site Injury Requiring Intervention, Both Venous and Arterial
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37847768Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.
- Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME StudyLink provided by the sponsor.
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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.
Mitchell Silver, MD principal investigator
OhioHealth Riverside
James Horowitz, MD principal investigator
NYU Langone Medical Center
11 sites in 1 country: 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 11 sites in United States.
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 1 inclusion and 12 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 20 Sep 2024). 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?
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding (time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.). 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 NCT04795167, which also lists 1 linked publication.
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 30 Apr 2025.