Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)

Ki vehet részt

• The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
• Clinical signs, symptoms and presentation consistent with acute PE
• PE symptom duration ≤ 14 days
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
• Systolic BP ≥ 90 mmHg (initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
• Stable HR < 130 BPM prior to the procedure

Ki nem vehet részt

• Prior PE <180 days from index procedure
• Thrombolytic use within 30 days prior to baseline CTA
• Cardiovascular or pulmonary surgery within the last 7 days
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Current participation in another investigational drug or device treatment study
• Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 70 mmHg by right heart catheterization
• Actively progressing cancer treated by chemotherapeutics
• Known bleeding diathesis or coagulation disorder
• History of severe or chronic pulmonary arterial hypertension
• History of uncompensated heart failure
• History of underlying lung disease that is oxygen dependent
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT)
• Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
• Life expectancy < 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
• Platelets < 100,000/μL
• eGFR <30 ml/min per 1.73 m2
• International normalized ratio (INR) > 3
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
• FiO2 requirement > 40% or > 6 LPM (to keep oxygen saturation > 90%)
• Hematocrit < 28% (Note: hematocrit required within 6 hrs. of index procedure)
• Major trauma injury severity score (ISS) > 15
• Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
• Left bundle branch block
• Contraindication to systemic or therapeutic doses of anticoagulants
• CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
• Female who is pregnant or nursing