evaluation of the magneto etrieve™ pe kit for endovascular thrombectomy in subjects with acute pulmonary embolism

Conditions: Pulmonary Embolism

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

Keywords: pulmonary embolism etrieve