FlowTriever2 Pulmonary Embolectomy Clinical Study

Study Overview
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Brief Summary
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The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.

Official Title
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FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: FlowTriever2 Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Completed Cases<br> | Device: FlowTriever2 Catheter<br>* The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patient Mortalities (48 hours) | Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter | 48 hours post procedure | 
| Number of Major Bleeding Occurrences | Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter | 48 hours post procedure | 
| Primary Safety: Serious Adverse Event 3 | 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 | Up to 30 days post procedure | 
| Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg) | The study's primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure and post-procedure. | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patient Mortalities (30 days) | All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) | Up to 30 days post procedure | 
| Number of Device-Related Serious Adverse Events | Number of device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) | Up to 30 days post procedure | 
| Number of recurrences of PE | Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) | Up to 30 days post procedure | 
| Change in Systolic Pulmonary Arterial Pressure (mmHg) | The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure | During procedure | 
| Number of Adjunctive Thrombolytic Uses | Incidence of adjunctive thrombolytic use | During procedure |