eTrieve II: Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: eTrieve PE Kit
|
Device: eTrieve PE Kit
Patients will be treated with the eTrieve PE Kit
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Mortality [within 30 days]
Mortality due to any cause within 30 days post-index 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE)
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PE symptom duration ≤ 14 days
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Filling defect in at least one main or lobar pulmonary artery on CTA
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Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading)
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Systolic blood pressure ≥ 90 mmHg
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Stable heart rate < 130 BPM prior to the index procedure
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Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters
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Written informed consent
Exclusion Criteria:
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Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE)
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PE within 3 months prior to screening assessment
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Thrombolytic use within 30 days prior to baseline CTA
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Pulmonary hypertension with peak systolic PAP > 70 mmHg
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Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg
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Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90%
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Any of the following laboratory findings (within 6 hours prior to index procedure):
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Hematocrit < 28%
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Platelets < 100,000/µL
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Serum creatinine > 1.8 mg/dL
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INR > 3
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Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment
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Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment
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Known presence of intracardiac clot
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Cardiovascular or pulmonary surgery within last 7 days
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Active malignancy and / or on chemotherapy
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Known bleeding diathesis or coagulation disorder
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Left bundle branch block
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History of severe or chronic pulmonary arterial hypertension
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History of left ventricular ejection fraction ≤ 30%
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History of decompensated heart failure
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History of underlying oxygen dependent lung disease
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History of chest irradiation
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History of Heparin Induced Thrombocytopenia (HIT)
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Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
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Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated
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Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
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Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention
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Life expectancy of < 90 days as determined by the investigator
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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
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Female who is pregnant or nursing
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Current participation in another investigational drug or device treatment study
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Previous enrollment in the eTrieve™ II Study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Magneto Thrombectomy Solutions
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KT1-CLN010