Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II

Ki vehet részt

• . Age ≥ 18 years < 80 years
• Acute onset of symptoms < 14 days consistent with the presence of pulmonary embolism
• CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• RV/LV ratio of > 0.9 on CTA as assessed by investigator (site determined)
• Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• Subject or subject's legally authorized representative (LAR) - applicable for US is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan-specific procedures
• Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visits

Ki nem vehet részt

• Unstable heart rate > 130 beats per minute prior to procedure
• Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure
• Cardiovascular or pulmonary surgery within last 30 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 artery pressure > 70 mmHg by right heart catheterization (site determined)
• Actively progressing cancer requiring chemotherapy
• 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)
• Known presence of right-to-left cardiac shunt
• History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
• Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
• Platelets < 100,000/μL
• Serum baseline creatinine > 1.8 mg/dL
• International normalized ratio (INR) > 3
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• Thrombolytic use within 30 days of baseline CTA
• Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• Hematocrit < 28%
• Major trauma injury severity score (ISS) > 15 within the past 14 days
• Left bundle branch block
• Patients on extracorporeal membrane oxygenation (ECMO)
• 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 mechanical thrombectomy intervention
• Life expectancy of < 365 days, as determined by Investigator
• Female who is pregnant or nursing
• Inability to lay flat for procedure