FlowTriever Pulmonary Embolectomy Clinical Study

Study Overview
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Brief Summary
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Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.

Official Title
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FlowTriever Pulmonary Embolectomy Clinical Study

Conditions
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Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism

Intervention / Treatment
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* Device: FlowTriever System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs, symptoms and presentation consistent with acute PE PE symptom duration ≤ 14 days CTA evidence of proximal PE RV/LV ratio ≥ 0.9 without syncope Systolic BP ≥ 90 mmHg Stable heart rate <130 BPM prior to procedure Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment Exclusion Criteria: Thrombolytic use within 30 days of baseline CTA Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90% Hematocrit < 28% within 6 hours of index procedure Platelets < 100,000/µL Serum creatinine > 1.8 mg/dL INR > 3 Major trauma ISS > 15 Presence of intracardiac lead in right ventricle or 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 Any contraindication to systemic or therapeutic doses of heparin or anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention Life expectancy of < 90 days 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: FlowTriever System<br> | Device: FlowTriever System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RV/LV Ratio | Change in RV/LV ratio from baseline to 48 hours | Baseline to 48 hours | 
| Number of Participants With Major Adverse Events | Device-related death, major bleeding, and treatment related AEs | Within 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE