CLEANer Aspiration for Pulmonary Embolism

Exclusion Criteria

• •tPA use within 14 days prior to baseline CTA
• •Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
• •Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
• •History of severe or chronic pulmonary hypertension
• •FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90%
• •Hematocrit \<28%
• •Platelets \<100,000/µL
• •Serum creatinine \>1.8 mg/dL
• •INR \>3
• •aPTT (or PTT) \>50 seconds on no anticoagulation
• •History of heparin-induced thrombocytopenia (HIT)
• •Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
• •Recent (within one month) history of active bleeding from a major organ
• •Absolute contraindication to anticoagulation
• •Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
• •Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• •Cardiovascular or pulmonary surgery within last 7 days
• •Cancer which requires active chemotherapy
• •Known serious, uncontrolled sensitivity to radiographic agents
• •Life expectancy \<90 days, as determined by investigator
• •Female who is pregnant
• •Intracardiac thrombus
• •Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
• •Simultaneous participation in another investigational study
• •Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
• •Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization