CLEANer Aspiration for Pulmonary Embolism

Inclusion Criteria:

• At least 18 years of age at the time of consent

• Clinical signs, symptoms, and presentation consistent with acute PE

• Onset of PE symptoms occurred within 14 days of presentation

• Filling defect in at least one main or lobar pulmonary artery evidenced by CTA

• RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9

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 maintainsystolic BP ≥90 mmHg

• Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does nothave diagnosis of pulmonary hypertension but peak PA >70 mmHg by right heartcatheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up toinvestigator 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), orintracranial 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 intraspinaldisease within 14 days

• Presence of intracardiac lead in the right ventricle or right atrium placed within 6months

• 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 membraneoxygenation (ECMO) or ECMO required to perform interventional procedure

• Simultaneous participation in another investigational study

• Patients with known coagulation disorders such as antiphospholipid, Protein C, andProtein S

• Presentation of PE with paradoxical emboli which may be diagnosed by concurrentstroke or concurrent arterialization