Clinical trial NCT05821426: Evaluation of the Magneto ETrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism
Official title: Evaluation of the Safety and Effectiveness of Magneto ETrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
eTrieve
Lead sponsor: Magneto Thrombectomy Solutions
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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):

  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

Primary outcomes:
measure: MAE
timeFrame: 48 hours
measure: RV/LV ratio
timeFrame: 48 hours
Secondary outcomes:
measure: Use of thrombolytics
timeFrame: within 48 hours
measure: ICU/hospitalization length
timeFrame: within 30 days
measure: Modified Miller score
timeFrame: at 48 hours
measure: Mortality
timeFrame: within 30 days
measure: Device related SAE
timeFrame: within 30 days
measure: PE reocurrence
timeFrame: within 30 days
Other outcomes:
Locations:
Study officials:
References: