Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05821426 | NOT YET RECRUITING | Pulmonary Embolism

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

Condition or disease

Pulmonary Embolism

Intervention/treatment

eTrieve PE Kit

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of the Safety and Effectiveness of Magneto ETrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Evaluation of the Magneto ETrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism

Location Details

NCT05821426

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found