Evaluation of the Magneto ETrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Embolism
• Interventions: Device: eTrieve PE Kit

• Registration Number: NCT05821426
• Lead Sponsor: Magneto Thrombectomy Solutions

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eTrieve PE Kit	eTrieve PE Kit	-

Primary Outcome Measures

Name	Time	Method
MAE	48 hours	Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)
RV/LV ratio	48 hours	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

Secondary Outcome Measures

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