FlowTriever2 Pulmonary Embolectomy Clinical Study

NCT05560763 | Completed Results DMC FDA Device

• 1 other identifier: 21-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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

  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 Outcomes (5)

• Secondary Safety Endpoint: Number of Patient Mortalities

  30 days post procedure (-5 / +15 days)

• Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events

  30 days post procedure (-5 / +15 days)

• Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE

  30 days post procedure (-5 / +15 days)

• Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)

  Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))

• Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use

  During Procedure (index procedure: approximately 50 minutes)

Study Arms (1)

All Subjects

EXPERIMENTAL

All participants who were treated with the FlowTriever System and FlowTriever2 Catheter.

Device: FlowTriever2 Catheter

Interventions

FlowTriever2 Catheter DEVICE

The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.

All Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (7)

Carondelet St. Joseph's Hospital

Tucson, Arizona, 85711, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Baptist Health

Louisville, Kentucky, 40207, United States

Location

Virtua Health

Camden, New Jersey, 08103, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ashleigh Willson
• Organization: Inari Medical

ashleigh.willson@inarimedical.com

925-330-3446

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: February 14, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: October 8, 2025
• Results First Posted: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)