Pulmonary EmbolismFLARE-FT2NCT05560763
FlowTriever2 Pulmonary Embolectomy Clinical Study
A study testing FlowTriever2 Catheter in people with Pulmonary Embolism, run by Inari Medical at 7 sites in United States.
Trial summary
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- FlowTriever2 Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Feb 2023to 9 Sep 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
- Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
- Stable heart rate < 130 BPM prior to procedure
- Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.
- FlowTriever2 Catheter enters the vasculature
Who cannot join
- Thrombolytic use within 30 days of baseline CTA
- Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28% (NOTE: hematocrit required within 6 hours of index procedure)
- Platelets < 100,000/μL
Show all 25Show fewer
- Serum creatinine > 1.8 mg/dL
- INR > 3
- Major trauma Injury Severity Score (ISS) > 15
- Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
- Cardiovascular or pulmonary surgery within last 7 days
- Actively progressing cancer
- Known bleeding diathesis or coagulation disorder
- Left bundle branch block
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- History of uncompensated heart failure
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus)
- Life expectancy of < 90 days, as determined by Investigator
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Virtua Health
Camden, New Jersey, 08103
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Baptist Health
Louisville, Kentucky, 40207
Yale University
New Haven, Connecticut, 06511
Memorial Health University Medical Center
Savannah, Georgia, 31404
Carondelet St. Joseph's Hospital
Tucson, Arizona, 85711
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
About this study
Official title: FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
Read the detailed description
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.
- Conditions
- Pulmonary Embolism
- Being tested
- FlowTriever2 Catheter
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowTriever2 CatheterDevice
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | All participants who were treated with the FlowTriever System and FlowTriever2 Catheter. Receives: Device: FlowTriever2 Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of:
- Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter
- Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter
- Intra-procedural device or procedure-related adverse events, including:
- Clinical deterioration defined by hemodynamic or respiratory worsening
- Pulmonary vascular injury related to FlowTriever2 Catheter
- Cardiac injury related to FlowTriever2 Catheter
Measured: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)
Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure.
Measured: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Secondary outcomes (5)
Secondary Safety Endpoint: Number of Patient Mortalities
Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Measured: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events
Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Measured: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE
Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Measured: 30 days post procedure (-5 / +15 days)
Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)
Change in systolic pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure
Measured: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use
Number of patients who received adjunctive thrombolytic medication during the index procedure
Measured: During Procedure (index procedure: approximately 50 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start14 Feb 2023
- Primary completion9 Sep 2024
- Study completion9 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.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560763
- Sponsor's protocol ID
- 21-001
- Acronym
- FLARE-FT2
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2022
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
- ClinicalTrials.gov ID
- NCT05560763
- Acronym / sponsor ID
- FLARE-FT2 / 21-001
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
Detailed description
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Device: FlowTriever2 CatheterAll participants who were treated with the FlowTriever System and FlowTriever2 Catheter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical signs and symptoms consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
- Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
Key exclusion criteria (25 listed)
- Thrombolytic use within 30 days of baseline CTA
- Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28% (NOTE: hematocrit required within 6 hours of index procedure)
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 |
|---|---|---|
| FlowTriever2 CatheterThe FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries. | Device | All Subjects |
Primary outcome
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
Time frame: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).
Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: * Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter * Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter * Intra-procedural device or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening * Pulmonary vascular injury related to FlowTriever2 Catheter * Cardiac injury related to FlowTriever2 Catheter
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure.
5 secondary outcomes
Secondary Safety Endpoint: Number of Patient Mortalities
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use
Time frame: During Procedure (index procedure: approximately 50 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowTriever2 Catheter in people with Pulmonary Embolism, run by Inari Medical at 7 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 8 inclusion and 25 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 8 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 7 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 23 Sep 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?
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) (time frame: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).). The study lists 2 primary outcomes in all. 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 8 Oct 2025.