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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: eTrieve PE Kit

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tami Abudi; Phone Number: +972 (52) 5989833; Email: tami@magts.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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):

  1. Hematocrit < 28%
  2. Platelets < 100,000/µL
  3. Serum creatinine > 1.8 mg/dL
  4. 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

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: eTrieve PE Kit	Device: eTrieve PE Kit; Patients will be treated with the eTrieve PE Kit

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Magneto Thrombectomy Solutions

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Embolism; eTrieve
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: KT1-CLN010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No