Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Study Overview
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Brief Summary
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Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism

Official Title
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Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: eTrieve PE Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE) PE symptom duration ≤ 14 days Filling defect in at least one main or lobar pulmonary artery on CTA Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading) Systolic blood pressure ≥ 90 mmHg Stable heart rate < 130 BPM prior to the index procedure Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters Written informed consent Exclusion Criteria: Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE) PE within 3 months prior to screening assessment Thrombolytic use within 30 days prior to baseline CTA Pulmonary hypertension with peak systolic PAP > 70 mmHg Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90% Any of the following laboratory findings (within 6 hours prior to index procedure): Hematocrit < 28% Platelets < 100,000/µL Serum creatinine > 1.8 mg/dL INR > 3 Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment Known presence of intracardiac clot Cardiovascular or pulmonary surgery within last 7 days Active malignancy and / or on chemotherapy Known bleeding diathesis or coagulation disorder Left bundle branch block History of severe or chronic pulmonary arterial hypertension History of left ventricular ejection fraction ≤ 30% History of decompensated heart failure History of underlying oxygen dependent lung disease History of chest irradiation History of Heparin Induced Thrombocytopenia (HIT) Any contraindication to systemic therapeutic doses of heparin or other anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention Life expectancy of < 90 days as determined by the investigator Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study Female who is pregnant or nursing Current participation in another investigational drug or device treatment study Previous enrollment in the eTrieve™ II Study

Ages Eligible for Study
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Minimum Age: 18 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: eTrieve PE Kit<br> | Device: eTrieve PE Kit<br>* Patients will be treated with the eTrieve PE Kit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAE | Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC) | 48 hours | 
| RV/LV ratio | Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of thrombolytics | Use of thrombolytics within 48 hours post-index procedure | within 48 hours | 
| ICU/hospitalization length | Length of stay in the Intensive Care Unit (ICU)/hospital, associated with the index thrombectomy procedure | within 30 days | 
| Modified Miller score | Change in the Modified Miller Score between baseline and 48 hours post-index procedure as assessed by the CTA core laboratory | at 48 hours | 
| Mortality | Mortality due to any cause within 30 days post-index procedure | within 30 days | 
| Device related SAE | Device-related serious adverse events within 30 days post-index procedure, as adjudicated by the CEC | within 30 days | 
| PE reocurrence | Symptomatic PE recurrence within 30 days post-index procedure | within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Embolism, eTrieve