FlowTriever2 Pulmonary Embolectomy Clinical Study (FLARE-FT2)

September 26, 2025 updated by: Inari Medical

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Carondelet St. Joseph's Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Health
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Virtua Health
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: All Subjects
All participants who were treated with the FlowTriever System and FlowTriever2 Catheter.
Device: FlowTriever2 Catheter
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
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.
Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoint: Number of Patient Mortalities
Time Frame: 30 days post procedure (-5 / +15 days)
Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
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)
Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
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)
Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
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))
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
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)
Number of patients who received adjunctive thrombolytic medication during the index procedure
During Procedure (index procedure: approximately 50 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inari Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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