Pulmonary EmbolismNCT05273762
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
A study testing FlowTriever in people with Pulmonary Embolism, run by Northwell Health at 2 sites in United States.
Trial summary
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- FlowTriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2022to 25 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- I1. ≥ 18 years of age
- I2. Clinical signs and symptoms of low-risk Intermediate pulmonary embolism defined per 2019 ESC Guidelines:
- Only one of the following:
- Presence of either RV strain or RV dilation on CT scan or Echo TTE
- 4th generation Troponin T > 0.01 ng/mL or 5th generation Troponin T >14 ng/L
- Troponin I > 51.4 ng/L (Northwell reference laboratory)
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- I3. sPESI score 0 or >1
- Signs of RV dysfunction on Echo TTE or CTPA or elevated cardiac biomarker levels may be present, despite a calculation of sPESI 0.
- I4. Echocardiogram, Computed Tomography Pulmonary Angiogram, or pulmonary angiographic evidence of proximal filing defect in at least one main, lobar, or segmental pulmonary artery with or without pulmonary infarction
- I5. Hemodynamically stable
Who cannot join
- E1. Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)
- E2. Unable to anti-coagulate with heparin or alternative
- E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated
- E4. Life expectancy < 6 months
- E5. Current participation in another study that may interfere with the patient's participation in this study.
- E6. Inability to consent
- E7. Patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding.
- E8. Subsegmental pulmonary embolism only
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Enrolling by invitation
Northern Westchester Hospital
Mount Kisco, New York, 10549
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Victoria Roselli, vroselli@northwell.edu
Bushra Mina, MD
About this study
Official title: Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Read the detailed description
In this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via FlowTriever.
- Conditions
- Pulmonary Embolism
- Being tested
- FlowTriever
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowTrieverDevice
Mechanical thrombectomy for pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever | Experimental | Not described Receives: Device: FlowTriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mMRC dyspnea score from
Measured: Baseline (state at time of admission to hospital) to 30-day follow-up.
Secondary outcomes (12)
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
Measured: Procedure to 30-day, 3-month, and 6-month follow up.
Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)
Measured: Pre-procedure to 30-day, 3-month, and 6-month follow up.
Echocardiogram Measurements: Change
Measured: Pre-procedure to 30-day and 6-month follow up
Echocardiogram Measurements: Change
Measured: From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up
ICU Length of Stay
Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit.
Measured: Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS
Hospital Duration
Measured: Length of index hospitalization, length median of 9.1 days per AHA journal
Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention
Measured: From end of index hospitalization to 30 days post-procedure, whichever comes first
Change in hemodynamic measurements
Measured: Before insertion of device during the procedure compared to 5 minutes after device is removed
Site Complications
Measured: Length of index hospitalization, length median of 9.1 days per AHA journal
Oxygen Requirement
Measured: Length of index hospitalization, length median of 9.1 days per AHA journal
All-cause Mortality
Measured: Length of index hospitalization, length median of 9.1 days per AHA journal
Bleeding Re-thrombosis Edema Pain
Measured: From end of index hospitalization to 30 days post-procedure, 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 posted10 Mar 2022
- Study start25 Jan 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Inari Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273762
- Sponsor's protocol ID
- 21-1117
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05273762
- Acronym / sponsor ID
- 21-1117
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Inari Medical
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Detailed description
In this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via FlowTriever.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowTriever | Experimental | Device: FlowTriever |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- I1. ≥ 18 years of age
- I2. Clinical signs and symptoms of low-risk Intermediate pulmonary embolism defined per 2019 ESC Guidelines:
- Presence of either RV strain or RV dilation on CT scan or Echo TTE
- 4th generation Troponin T > 0.01 ng/mL or 5th generation Troponin T >14 ng/L
- Troponin I > 51.4 ng/L (Northwell reference laboratory)
Key exclusion criteria (8 listed)
- E1. Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)
- E2. Unable to anti-coagulate with heparin or alternative
- E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated
- E4. Life expectancy < 6 months
- E5. Current participation in another study that may interfere with the patient's participation in this study.
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 |
|---|---|---|
| FlowTrieverMechanical thrombectomy for pulmonary embolism | Device | FlowTriever |
Primary outcome
Change in mMRC dyspnea score from
Time frame: Baseline (state at time of admission to hospital) to 30-day follow-up.
12 secondary outcomes
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
Time frame: Procedure to 30-day, 3-month, and 6-month follow up.
Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)
Time frame: Pre-procedure to 30-day, 3-month, and 6-month follow up.
Echocardiogram Measurements: Change
Time frame: Pre-procedure to 30-day and 6-month follow up
Echocardiogram Measurements: Change
Time frame: From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up
ICU Length of Stay
Time frame: Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS
Hospital Duration
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention
Time frame: From end of index hospitalization to 30 days post-procedure, whichever comes first
Change in hemodynamic measurements
Time frame: Before insertion of device during the procedure compared to 5 minutes after device is removed
Site Complications
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
Oxygen Requirement
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
All-cause Mortality
Time frame: Length of index hospitalization, length median of 9.1 days per AHA journal
Bleeding Re-thrombosis Edema Pain
Time frame: From end of index hospitalization to 30 days post-procedure, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowTriever in people with Pulmonary Embolism, run by Northwell Health at 2 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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Roselli, Clinical Research Coordinator (212-434-3695, vroselli@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mMRC dyspnea score from (time frame: Baseline (state at time of admission to hospital) to 30-day follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.