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Not yet recruiting NCT05821426

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

No phase Interventional Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eTrieve PE Kit.
Who it may be relevant to
Registry conditions: Pulmonary Embolism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device eTrieve PE Kit
    Patients will be treated with the eTrieve PE Kit

Primary outcome measures

  • MAE [Time frame: 48 hours]
  • RV/LV ratio [Time frame: 48 hours]
Secondary outcome measures (6)
  • Use of thrombolytics [Time frame: within 48 hours]
  • ICU/hospitalization length [Time frame: within 30 days]
  • Modified Miller score [Time frame: at 48 hours]
  • Mortality [Time frame: within 30 days]
  • Device related SAE [Time frame: within 30 days]
  • PE reocurrence [Time frame: within 30 days]

Eligibility 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):
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05821426 · KT1-CLN010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗