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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Akura Medical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Prior PE \<180 days from index procedure
Thrombolytic use within 30 days prior to baseline CTA
Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
Platelets \< 100,000/μL
eGFR \<30 ml/min per 1.73 m2
International normalized ratio (INR) \> 3
Major trauma injury severity score (ISS) \> 15
Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
Cardiovascular or pulmonary surgery within the last 7 days
Actively progressing cancer treated by chemotherapeutics
Known bleeding diathesis or coagulation disorder
Left bundle branch block
History of severe or chronic pulmonary arterial hypertension
History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
History of uncompensated heart failure.
History of underlying lung disease that is oxygen dependent
History of chest irradiation
History of heparin-induced thrombocytopenia (HIT)
Contraindication to systemic or therapeutic doses of anticoagulants
Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
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)
Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
Female who is pregnant or nursing
Current participation in another investigational drug or device treatment study
Clareo Health | 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)
