Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Ki vehet részt

• Age ≥ 18 and ≤ 80 years
• Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
• Subject is willing and able to comply with all protocol required follow-up visits
• PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure
• PE diagnosis ≤ 48 hours prior to index procedure
• CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
• CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination
• Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)
• Stable heart rate < 130 BPM prior to index procedure
• Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment

Ki nem vehet részt

• Prior PE ≤ 180 days from index procedure
• Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
• Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial
• Current hospitalization for other condition(s)
• Pulmonary hypertension with peak pulmonary artery systolic pressure > 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)
• Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
• Platelets < 100,000/μL
• Serum creatinine > 1.8 mg/dL
• International normalized ratio (INR) > 3
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• Thrombolytic use ≤ 14 days of baseline CTA
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• Hematocrit < 28% within 6 hours of index procedure
• Left bundle branch block
• Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus
• Life expectancy of < 90 days, as determined by Investigator
• Female who is pregnant or nursing
• Subject on extracorporeal membrane oxygenation (ECMO)