Safety and Effectiveness of the ATC System in the Treatment of Acute PE

Ki vehet részt

• Patient is ≥ 18 and ≤ 90 years old
• Clinical signs and symptoms consistent with acute PE for < 14 days
• CTA evidence of proximal PE
• RV/LV ratio > 0.9
• Systolic BP ≥90 mmHg without the need for vasopressors
• Stable heart rate (HR) < 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• 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

Ki nem vehet részt

• Prior PE < 180 days from index procedure
• Thrombolytic use < 30 days prior to baseline CTA
• Major trauma injury severity score (ISS) >15 prior to screening assessment
• Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
• Cardiovascular or pulmonary surgery within 7 days of index procedure
• 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 artery systolic pressure (PASP) >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 decompensated heart failure
• History of underlying lung disease that is oxygen dependent
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT)
• Life expectancy <90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
• Platelets count <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%
• FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
• Hematocrit <28%
• Left bundle branch block
• Contraindication to systemic or therapeutic doses of anticoagulants
• Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
• Female who is pregnant or nursing