FlowTriever2 Pulmonary Embolectomy Clinical Study (FLARE-FT2)

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: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: FlowTriever2 Catheter

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: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 worseningPulmonary vascular injury related to FlowTriever2 CatheterCardiac 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)	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

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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	During Procedure (index procedure: approximately 50 minutes)

Collaborators and Investigators

• Sponsor: Inari Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID 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